MEDLINE INDUSTRIES, LP - Northfield
Northfield, IL, US
MEDLINE INDUSTRIES, LP - Northfield appears in FDA device records in Northfield, IL. FDA records list 414 510(k) clearances between and , 89 PMA records and 9 registered establishments. As of , FDA records show 1,528 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
7 namesFDA records resolved to MEDLINE INDUSTRIES, LP - Northfield carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Coloplast Corp Skin Care Divrecall
- Coloplast Corp.registration, 510(k), PMA, recall
- Coloplast Manufacturing US, LLC.registration, 510(k), enforcement report, recall
- MEDLINE INDenforcement report, recall
- Medline Industries, LPregistration, 510(k), enforcement report, recall
- MEDLINE INDUSTRIES, LP - Laredoregistration
- MEDLINE INDUSTRIES, LP - SPTregistration, enforcement report, recall
510(k) clearance history
Showing 50 of 414FDA records hold 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield between 1977 and 2026. The busiest year on record is 2020, with 22. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 6 |
| 1978 | 4 |
| 1979 | 7 |
| 1980 | 2 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 6 |
| 1984 | 16 |
| 1985 | 6 |
| 1986 | 5 |
| 1987 | 11 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 7 |
| 1992 | 9 |
| 1993 | 6 |
| 1994 | 3 |
| 1995 | 6 |
| 1996 | 13 |
| 1997 | 9 |
| 1998 | 6 |
| 1999 | 3 |
| 2000 | 5 |
| 2001 | 6 |
| 2002 | 2 |
| 2003 | 5 |
| 2004 | 13 |
| 2005 | 6 |
| 2006 | 9 |
| 2007 | 3 |
| 2008 | 6 |
| 2009 | 5 |
| 2010 | 10 |
| 2011 | 14 |
| 2012 | 15 |
| 2013 | 9 |
| 2014 | 6 |
| 2015 | 14 |
| 2016 | 12 |
| 2017 | 11 |
| 2018 | 20 |
| 2019 | 12 |
| 2020 | 22 |
| 2021 | 10 |
| 2022 | 20 |
| 2023 | 14 |
| 2024 | 18 |
| 2025 | 8 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | DYB | Substantially Equivalent | |
| K262045 | Luja Soft | EZD | Substantially Equivalent | |
| K254287 | Medline Reusable Blood Pressure Cuff | DXQ | Substantially Equivalent | |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | BZE | Substantially Equivalent | |
| K251687 | Konig Bell Circumcision Clamp | HFX | Substantially Equivalent | |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | DXC | Substantially Equivalent | |
| K250345 | Medline Bag Decanter | LHI | Substantially Equivalent | |
| K252140 | Heylo™ System | EXB | Substantially Equivalent | |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | BTT | Substantially Equivalent | |
| K251116 | Luja Coudé | EZD | Substantially Equivalent | |
| K250270 | Luja Set | EZD | Substantially Equivalent | |
| K243888 | Medline UNITE® REFLEX® Hybrid Nitinol Implant System | JDR | Substantially Equivalent | |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | FYA | Substantially Equivalent | |
| K242370 | Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A)) | GEI | Substantially Equivalent | |
| K241778 | Hudson RCI Comfort Flo® CubCannula™ | BTT | Substantially Equivalent | |
| K242049 | SureCath Set | EZD | Substantially Equivalent | |
| K241210 | Luja Coude | EZD | Substantially Equivalent | |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | FED | Substantially Equivalent | |
| K242473 | Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) | PAH | Substantially Equivalent | |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | BTT | Substantially Equivalent | |
| K234132 | Medline Reusable Sterilization Wrappers | FRG | Substantially Equivalent | |
| K241359 | Medline UNITE® MIS Foot Recon Screw System | HWC | Substantially Equivalent | |
| K241028 | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) | EZD | Substantially Equivalent | |
| K234032 | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line | BZE | Substantially Equivalent | |
| K233411 | Folysil Silicone Catheter | EZL | Substantially Equivalent | |
| DEN210049 | Medline ART Skin Harvesting System | QYK | Unknown | |
| K233151 | PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) | FRO | Substantially Equivalent | |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in) | FRO | Substantially Equivalent | |
| K233526 | Medline Open-back Level 3 Protective Gown | QPC | Substantially Equivalent | |
| K230235 | Medline Luer Lock Syringes | FMF | Substantially Equivalent | |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | CAF | Substantially Equivalent | |
| K231211 | Medline ComfortTemp Patient Warming System | DWJ | Substantially Equivalent | |
| K230602 | Hudson RCI® TurboMist™ Nebulizer System | CAF | Substantially Equivalent | |
| K233101 | Luja Coude (20108 Male CH18 - large packaging) | EZD | Substantially Equivalent | |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | BTT | Substantially Equivalent | |
| K232905 | Medline UNITE® REFLEX® Nitinol Staple Kit | JDR | Substantially Equivalent | |
| K231907 | Medline Safety Insulin and TB Syringes | MEG | Substantially Equivalent | |
| K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | OTM | Unknown | |
| K230165 | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) | EZD | Substantially Equivalent | |
| K231885 | Medline UNITE® REFLEX® Nitinol Staple System | JDR | Substantially Equivalent | |
| K223821 | Self-Cath Closed System | FCM | Substantially Equivalent | |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) | CAF | Substantially Equivalent | |
| K223236 | Medline Surgical Face Mask and Medline Procedural Face Mask | FXX | Substantially Equivalent | |
| K221874 | Altis Single Incision Sling System | PAH | Substantially Equivalent | |
| K222665 | Medline UNITE® Ankle Fusion Plating System | HRS | Substantially Equivalent | |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | FMF | Substantially Equivalent | |
| K221401 | Self-Cath and Self-Cath Plus | EZD | Substantially Equivalent | |
| K212911 | Konig Mogen Clamp | HFX | Substantially Equivalent | |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | BWF | Substantially Equivalent | |
| K220365 | Gemini Sterilization Wrap | FRG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9610694 | 3002806731 | COLOPLAST A/S | HOLTEDAM 1, HUMLEBAEK Hovedstaden DK-3050 DK | 2026 | and 12 more, listed in full below |
| 2125050 | 2125050 | COLOPLAST MANUFACTURING US, LLC | 1601 W River Rd N, MINNEAPOLIS, MN 55411 US | 2026 | and 8 more, listed in full below |
| 3032906574 | 3032906574 | Coloplast Manufacturing US LLC | 680 E Travelers Trl Ste 800, Burnsville, MN 55337 US | 2026 | |
| 3030087693 | 3030087693 | Coloplast Manufacturing US, LLC. | 4008 Heritage Drive, Brookshire, TX 77423 US | 2026 | |
| 3005595283 | 3005595283 | MEDLINE INDUSTRIES, LP - Laredo | 12001 General Milton Drive, LAREDO, TX 78045 US | 2026 | and 86 more, listed in full below |
| 1417592 | 1417592 | MEDLINE INDUSTRIES, LP - Northfield | Three Lakes Drive, Northfield, IL 60093 US | 2026 | and 613 more, listed in full below |
| 1423395 | 3000717925 | MEDLINE INDUSTRIES, LP - SPT | 1170 S Northpoint Blvd, Waukegan, IL 60085 US | 2026 | and 55 more, listed in full below |
| 2125337 | 2125337 | Medline Industries, LP | 1940 Commerce Dr, North Mankato, MN 56003 US | 2026 | |
| 3007128716 | 3007128716 | Medline Industries, LP | 2495 General Armistead Avenue Suite B, Norristown, PA 19403 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CAZAnesthesia Conduction Kit
- EAJApron, Leaded
- CBTArterial Blood Sampling Kit
- BTCBag, Reservoir
- DXQBlood Pressure Cuff
- BTXBoard, Arm (With Cover), Sterile
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- CATCannula, Nasal, Oxygen
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- BSOCatheter, Conduction, Anesthetic
- DQOCatheter, Intravascular, Diagnostic
- BZBCatheter, Nasal, Oxygen
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DXCClamp, Vascular
- DSSClip, Vascular
- BTICompressor, Air, Portable
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- BSKCuff, Tracheal Tube, Inflatable
- CBHDevice, Fixation, Tracheal Tube
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- DWPDilator, Vessel, Surgical
- BYHDrain, Tee (Water Trap)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- DRXElectrode, Electrocardiograph
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- DXTInjector And Syringe, Angiographic
- DZNInstruments, Dental Hand
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- CCWLaryngoscope, Rigid
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- DQAOximeter
- BTAPump, Portable, Aspiration (Manual Or Powered)
- DPDRadioimmunoassay, Digoxin (3-H), Rabbit Antibody, Charcoal Sep.
- CANRegulator, Pressure, Gas Cylinder
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BWFSpirometer, Therapeutic (Incentive)
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)
- CCXSupport, Patient Position
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DWJSystem, Thermal Regulating
- DRSTransducer, Blood-Pressure, Extravascular
- BYZTrap, Sterile Specimen
- BYYTube, Aspirating, Flexible, Connecting
- BTOTube, Tracheostomy (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- BTMVentilator, Emergency, Manual (Resuscitator)
- BZDVentilator, Non-Continuous (Respirator)
Recall records
Showing 25 of 1,528| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3079-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3078-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3077-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3076-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY ADMISSION BAG DYKA1054F | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3075-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B DYKA1384C WELCOME KIT DYKS1206D | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3074-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL PREOP KIT DYKS1584A PRE OP KIT DYKS1216I PRE-OP KIT DYKM1398B | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3073-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD CULTURE-NB DYNDH2089 BLOOD DRAW KIT DYLAB1081 FLOORS BLOOD DRAW KIT DYLAB1080 PEDS BLOOD CULTURE KIT DYNDH1445C PERIPHERAL BLOOD CULTURE KIT DYNDH2350 WICHITA BLOOD CULTURE COLLECT DYNDH2093 | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3072-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT DYNDH1487A | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3071-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684 | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3070-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073 DRAWER 4 CIRCULATION ACC011088 DRAWER 5 - LEFT BOX ACC011067 LABOR TRIAGE KIT - LF #13232 DYKM1564 DYKM1564A LINEN UNIVERSAL PACK DYNJT10325 MAC KIT DYKS1089B NICU LINE PACK DYNJ63410 PEDIATRIC BLOOD CULTURE KIT DYNDH1363 RRMC CODE CART DRAWER 3 ACC010770 STANFORD TIME TO POSITIVITY DYNDH1591 STUDENT PRACTICE BAG W LOGO EDUC1043 EDUC1043A SUTURED SHEATH W/SCI #113198 DYKM1496 IV START KIT DYNDV2520 | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3069-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN TRAY-LF DYNJ42832B | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3068-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-3067-2026 | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. | Class II | Open, Classified | |
| Z-2993-2026 | Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT); 3) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT); 4) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT); 5) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT); 6) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL HTD, DUAL LIMB,COLUMN, Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT); 7) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD SINGLE LIMB,INFANT, Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT); 8) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD,INFANT,HTD,COLUMN,DRN, Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT); 9) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT); 10) MEDLINE HUDSON RCI,ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT); 11) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT). | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress. | Class II | Open, Classified | |
| Z-2992-2026 | Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); 5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18). | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress. | Class II | Open, Classified | |
| Z-2991-2026 | Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress. | Class II | Open, Classified | |
| Z-3029-2026 | Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K. | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified | |
| Z-3028-2026 | Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A. | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified | |
| Z-3027-2026 | Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit SKU DYNJ903467L. | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified | |
| Z-3026-2026 | Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014. | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified | |
| Z-3025-2026 | Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ906013I; 10) GYN LAPAROSCOPIC PACK, Medline Kit SKU DYNJ909394B; 11) GYN ROBOTIC, Medline Kit SKU DYNJ909526B; 12) GYN ROBOTIC, Medline Kit SKU DYNJ909526C; 13) GYN ONC ROBOTIC, Medline Kit SKU DYNJ910180; 14) GYN ROBOTIC, Medline Kit SKU DYNJ910181; 15) GYN ROBOTIC, Medline Kit SKU DYNJ910181A; 16) ROBOTICS, Medline Kit SKU DYNJ912062. | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified | |
| Z-3024-2026 | Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B; 9) DIEP FLAP, Medline Kit SKU DYNJ910832A; 10) C-SECTION, Medline Kit SKU DYNJ911236; 11) LAPAROTOMY, Medline Kit SKU DYNJ911243; 12) OPEN HEART A&B, Medline Kit SKU DYNJ911245; 13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332; 14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A. | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified | |
| Z-3023-2026 | Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified | |
| Z-3022-2026 | Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M. | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified | |
| Z-3021-2026 | Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S | Kits contain a potentially contaminated component which were recalled by the manufacturer | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain