Salter Labs
Grand Rapids, MI, US
Salter Labs appears in FDA device records in Grand Rapids, MI. FDA records list 74 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 70 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
6 namesFDA records resolved to Salter Labs 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.
- Ethox International510(k), recall
- Salter Laboratories, Division of Regulatory Affairsrecall
- Sun Med, LLCenforcement report, recall
- SunMed Group Holdings, LLCregistration
- SunMed Holdings, LLCenforcement report, recall
- Ventlab, LLC510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 74FDA records hold 74 510(k) clearances for Salter Labs between 1978 and 2026. The busiest year on record is 1986, with 8. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1984 | 1 |
| 1986 | 8 |
| 1987 | 7 |
| 1988 | 3 |
| 1989 | 6 |
| 1990 | 7 |
| 1991 | 4 |
| 1992 | 1 |
| 1996 | 3 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 3 |
| 2011 | 2 |
| 2012 | 1 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | CCL | Substantially Equivalent | |
| K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff | BTR | Substantially Equivalent | |
| K173373 | SafeT T-Piece Resuscitator | BTL | Substantially Equivalent | |
| K161719 | Salter Labs Bubble Humidifier | BTT | Substantially Equivalent | |
| K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | MNR | Substantially Equivalent | |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | NFB | Substantially Equivalent | |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | Substantially Equivalent | |
| K143700 | CPAP Cannulaide | BZD | Substantially Equivalent | |
| K142416 | Luma Wrap | PDH | Substantially Equivalent | |
| K120118 | VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER | CAP | Substantially Equivalent | |
| K102674 | CUFF SENTRY | BSK | Substantially Equivalent | |
| K093617 | VENTLAB 6000 SERIES HUMIDIFIER | BTT | Substantially Equivalent | |
| K093525 | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE | CCK | Substantially Equivalent | |
| K092685 | PNEUMOTHERML, MODEL: 5800 | BZQ | Substantially Equivalent | |
| K090840 | VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. | CAF | Substantially Equivalent | |
| K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | ODR | Substantially Equivalent | |
| K063813 | VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA | CCK | Substantially Equivalent | |
| K061962 | SURGI-CUF REUSABLE, RS SERIES | DXQ | Substantially Equivalent | |
| K051313 | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER | MNR | Substantially Equivalent | |
| K040202 | SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM | BZD | Substantially Equivalent | |
| K040726 | VENTLAB NASAL CPAP CANNULA | BZD | Substantially Equivalent | |
| K030271 | VENTLAB BACTERIAL FILTER, MODEL BF100 | CAH | Substantially Equivalent | |
| K020281 | MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | |
| K014056 | SALTER LABS MODIFIED NEBUTECH NEBULIZER | CAF | Substantially Equivalent | |
| K013308 | VENTLAB HYPERINFLATION BAG SYSTEM | NHK | Substantially Equivalent | |
| K012842 | V*CARE MANUAL RESUSCITATOR | BTM | Substantially Equivalent | |
| K992285 | SALTER AIRE COMPRESSOR | CAF | Substantially Equivalent | |
| K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | CAF | Substantially Equivalent | |
| K991788 | SALTER LABS PEP DEVICE | CAF | Substantially Equivalent | |
| K990678 | PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) | NFB | Substantially Equivalent | |
| K990098 | VENTLAB VERIFY II | BTR | Substantially Equivalent | |
| K983403 | SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER | CAF | Substantially Equivalent | |
| K981944 | BREATHERITE | CAF | Substantially Equivalent | |
| K962879 | SALTERLABS 8660 SERIES NEBULIZER | CAF | Substantially Equivalent | |
| K962085 | SALTER LABS 8990 SERIES NEBULIZER | CAF | Substantially Equivalent | |
| K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | CAF | Substantially Equivalent | |
| K913900 | V*CARE MANUAL RESUSCITATOR, CAT#VR-1000 | BTM | Substantially Equivalent | |
| K912434 | SALTER LABS INFANT NASAL CPAP CANNULA | BZD | Substantially Equivalent | |
| K912174 | SALTER LABS DISPOSABLE NIPPLE AND NUT | CAN | Substantially Equivalent | |
| K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | CAT | Substantially Equivalent | |
| K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | BYG | Substantially Equivalent | |
| K903539 | SALTER LABS MODEL #1015 | CBH | Substantially Equivalent | |
| K903881 | VENTLAB VENT-MASK, CAT# VR 0010/20/30 | BSJ | Substantially Equivalent | |
| K900591 | VENT-TRAP CAT# WR1000 | BYH | Substantially Equivalent | |
| K900115 | VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B | CAN | Substantially Equivalent | |
| K900236 | ET-RESTRAINT CAT. # ER 4000 | CBH | Substantially Equivalent | |
| K896897 | VENTLAB ANESTHESIA CIRCUIT AC 6000 | CAI | Substantially Equivalent | |
| K896439 | TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE | BZO | Substantially Equivalent | |
| K894350 | SALTER LABS MODEL #4009 SAMPLE LINES | CCK | Substantially Equivalent | |
| K892407 | MODIFIED DEMAND NASAL OXYGEN CANNULA | NFB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004748541 | 3004748541 | Salter Labs | 30 Spur Drive, El Paso, TX 79906 US | 2026 | and 24 more, listed in full below |
| 1314417 | 1314417 | SunMed Group Holdings, LLC | 2710 Northridge Dr NW Ste A, Grand Rapids, MI 49544 US | 2026 | and 122 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BTQAirway, Nasopharyngeal
- CAEAirway, Oropharyngeal, Anesthesiology
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- BYEAttachment, Breathing, Positive End Expiratory Pressure
- BTCBag, Reservoir
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)
- BTYCalculator, Predicted Values, Pulmonary Function
- BZCCalculator, Pulmonary Function Data
- CATCannula, Nasal, Oxygen
- BZBCatheter, Nasal, Oxygen
- BSYCatheters, Suction, Tracheobronchial
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BXJClip, Nose
- BYDCondenser, Heat And Moisture (Artificial Nose)
- BZAConnector, Airway (Extension)
- BSKCuff, Tracheal Tube, Inflatable
- CBHDevice, Fixation, Tracheal Tube
- BYHDrain, Tee (Water Trap)
- DPSElectrocardiograph
- CAHFilter, Bacterial, Breathing-Circuit
- BXYFlowmeter, Calibration, Gas
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated
- BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- CCWLaryngoscope, Rigid
- BSJMask, Gas, Anesthetic
- BYGMask, Oxygen
- BYFMask, Oxygen, Low Concentration, Venturi
- BZHMeter, Peak Flow, Spirometry
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)
- BZQMonitor, Breathing Frequency
- BYPMouthpiece, Breathing
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- DQAOximeter
- BYIPercussor, Powered-Electric
- BRWProtector, Dental
- CANRegulator, Pressure, Gas Cylinder
- BZOSet, Tubing And Support, Ventilator (W Harness)
- BZGSpirometer, Diagnostic
- BWFSpirometer, Therapeutic (Incentive)
- BZSStethoscope Head
- BXNStimulator, Nerve, Battery-Powered
- BTKStrap, Head, Gas Mask
- BSRStylet, Tracheal Tube
- CCXSupport, Patient Position
- BYYTube, Aspirating, Flexible, Connecting
- BTRTube, Tracheal (W/Wo Connector)
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- BYXTubing, Pressure And Accessories
- CBPValve, Non-Rebreathing
- CBKVentilator, Continuous, Facility Use
- BTMVentilator, Emergency, Manual (Resuscitator)
- BTLVentilator, Emergency, Powered (Resuscitator)
- BZDVentilator, Non-Continuous (Respirator)
- BSBWarmer, Blood, Non-Electromagnetic Radiation
Recall records
Showing 25 of 70| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1117-2026 | Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | Class I | Open, Classified | |
| Z-1116-2026 | Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | Class I | Open, Classified | |
| Z-1115-2026 | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | Class I | Open, Classified | |
| Z-1114-2026 | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | Class I | Open, Classified | |
| Z-1904-2025 | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. | The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia. | Class I | Open, Classified | |
| Z-1814-2025 | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death. | Class I | Open, Classified | |
| Z-0369-2024 | Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resuscitator REF #s: CPRM3312FM, CPRM3312FM123, CPRM3312FPM, CPRM3312FPM3, CPRM3312FPMC, CPRM3312M, CPRM3312M3, CPRM3312P3M3, CPRM3312PM, CPRM3312PM2, CPRM3312PMC2, CPRM3312PMTD1, CPRM3312PMX, CPRM3312PWM, CPRM3322FM, CPRM3322M, CPRM3322PM; 3. Pediatric Resuscitator REF #s: CPRM2216FM, CPRM2216FM3, CPRM2216FPM, CPRM2216FPM3, CPRM2216FPMC, CPRM2216M, CPRM2216P3M3, CPRM2216PCM, CPRM2216PM, CPRM2216PM6, CPRM2226FM, CPRM2226FM3, CPRM2226FPM, CPRM2226FPWM, CPRM2226M; 4. Small Adult Resuscitator REF #s: CPRM4416FPMC, CPRM4416M, CPRM4426M. | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-0368-2024 | Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA. | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-0367-2024 | Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN3100MB-D1, VN3100MB-M00-0, VN3100MB-M1, VN3100OBP, VN3100MB-B, VN3100MB-I, VN3100MBP-000, VN3100MBP-2, VN3100MB-PW2, VN3100MBP, VN3100MBP-D1, VN3100MBPW-D2, VN3100MBP-F, VN3100MXK-2, VN3100MX-F, VN3100MC-2, VN3100MC, VN3100MC-B, VN3100MC-D1, VN3100MC-2U, VN3106MC-M1-2V, VN3104MCFB- M01, VN3106MC-D2V, VN3106MC-M1V, VN3100MCP-2, VN3100MCP, VN3106MCPF- M1V, VN3100MBF; 3. V-Care Pediatric Resuscitator REF #s: VN2100MB, VN2102MB, VN2102MBF, VN2102OBP, VN2100MBF, VN2100MBP, VN2100MB-PW, VN2102MX, VN2102MX-F, VN2100MX-M123, VN2100MC, VN2102MC, VN2102MC-B, VN2102MCP, VN2100MCP; 4. V-Care Small Adult Resuscitator REF #s: VN5000MB, VN5002MB, VN5100MB-F, VN5000MBPF, VN5000MBPF-I, VN5000MX, VN5100MX-F, VN5000MX-N, VN5000MXP, VN5000MXP-K, VN5000MC, VN5102MC, VN5100MCP, VN5000MC-N. | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-0366-2024 | Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0; 3. STAT-Check Pediatric Resuscitator REF #: SC8121B. | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-0365-2024 | Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, SS3200MBF-2, SS3204MBF-2, SS3200MB- PWS10, SS3206MCP-S1, SS3204MB, SS3204MC-P2, SS3200MB, SS3200MBP-2, SS3200MBF, SS3200MB-I, SS3200MBP, SS3200OB, SS3200MC, SS3200MC-P2; 2. SafeSpot Safe Spot Bag, D1 Mask with Inflation Bag Reservoir, Manometer, PEEP Valve, and 40cm Pop-Off REF # PRO-1927. | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-0364-2024 | Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F. | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-0363-2024 | Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resuscitator REF #s: 6112HZ, 6123HZ, 6125HZ, 6200HZ, 6106HZ, 6118HZ, 6107HZ, 6013HZ, 6117HZ, 6116HZ, 6019HZ, HZI6000, 6009HZ; 3. Horizon Pediatric Resuscitator REF #s: 8106HZ, 8119HZ, 8115HZ, 8107HZ, 8010HZ, 8004HZ, 8105HZ, 8113HZ, 8109HZ, 8116HZ, 8003HZ, HZI8100; | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-0362-2024 | Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant Resuscitator REF #s: BT2415K, BT2416, BT2032, BT2016, BT2035, BT2216, BT2036, BT2023, BT2026, BT2220-2, BT2020, BT2220, BT2220F, BT2215, BT2415, BT2014, BT2027, BT2015, BT2029, BT2037, BT2048, BT2034, BT2034W, BT2234, BT2234FK; 4. BreathTech Pediatric Resuscitator REF #s: BT4016, BT4019, BT4013, BT4018, BT4013F, BT4015, BT4006-N, BT4040, BT4022, BT4045, BT4024. | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-0361-2024 | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW, AF5140MB-PW, AF1140MB-I, AF5140MB-I, AF5140MBN, AF1140MBS, AF5140MBS, AF1140MB-X, AF5140MB-X, AF1140MB-P, AF5140MBP, AF1140MB-K, AF5140MBS-I,AF5140MBPF-G10, AF5140MBP-G10, AF1140MBP-T, AF5140MBP-I, AF1140MBP-K, AF1140MBC-N, AF1140MBP-2, AF1140MC, AF5140MC, AF1140MCP, AF5140MC-P, AF1100MB, AF5100MB, AF5100MC, AF1140MC-M5, AF1140MB-TM5, AF1140MBP-TM5, AF1100MC, AF1140OB, AF1140MBP-M5, AFW1140MB,AF1140MBS-P, AF1000MBN-20, AF5102MBP, AF1100MB-N, AF1100MC-P, AF1140MB, AF1140MB-E, AF1140MB-N, AF1140MB-R, AF1140MBS-K, AF1140MBSP-I, AF1142MB, AF1100MBS, AF1100MB-MMC, AF1100MB-PWG1, AF1100MBP; 2. AirFlow Child Resuscitator REF #s: AF4100MCP, AF4140MB, AF4140MB-I, AF4140MBP, AF4140MB-PI, AF4100MB, AF4100MBP, AF4100OB, AF4140MB-D23, AF4140OBP, AF4140MCP-D3, AF4140MC; 3. AirFlow Infant Resuscitator REF #s: AF3140OB, AF3144MB, AF3104MB-PW, AF3100MBP- M0D1, AF3100MBP- M012, AF3140MB-M000, AF3140MB-D2, AF3140MB-D1, AF3140MB-S1, AF3140MB-2B, AF3140MB-I, AF3140MB-K, AF3100MB-PW, AF3100MB-PTS1, AF3100MB-M0- D1, AF3100OC, AF3100MC-2, AF3100MC, AF3106MC-2, AF3140MCP-K, AF3140MC-2B, AF3100MCP-2, AF3140MC- M0D12, AF3144MCP- M1M00, AF3100OB, AF3140MB, AF3140MB-M0, AF3140MB-2, AF3140MB-M1, AF3140MB-PW, AF3140MB-P, AF3140MB-D12I, AF3140MBP-2, AF3140MC, AF3140MCP, AF3140MCPF, AF3100MB, AF3100MB-M0, AF3100MB-2, AF3100MB-M1, AF3100MB-X, AF3100MBP, AF3100MB-M01, AF3100MBP-M01, AF3100MBP-2, AF3100MBP-D12, AF3100MCP; 4. AirFlow Pediatric Resuscitator REF #s: AF2100OB, AF2100MB-3, AF2102OB, AF2100MB-D5, AF2140OB, AF2102MBP-2, AF2102MBPW-D4, AF2102MBP-M3, AF2140MB-2, AFW2142OB, AF2140MB-D4, AF2140MB-D43, AF2140MB-P2, AF2144MB, AFW2142MB-2, AF2142MB-D3, AF2242MBP, AF2142MBS-I, AF2142MBP- 224OT, AF2140MBPW- D23, AF2140MB-I, AF2140MB-K, AF2140MB-S, AF2140MBP-K, AF2100MB-PW, AF2100MB-MMC, AF2102MBP, AF2100MB- PWTS4, AF2140MCPF, AF2100MC, AF2102MC, AF2142MC-M01, AF2140MC, AF2142MC-D34, AF2140MCP-D4, AF2140MC-PT, AF2140MCP-K, AF2142MCP, AF2100MCP, AF2102MB, AF2102MCP, AF2102MC-PT, AF2142OB, AF2142OBNS, AF2142MB, AF2142MB-3, AF2142MB-2, AF2142MB-M5E, AF2142MB-PW, AF2142MBP, AF2142MB-K, AF2142MBP-2, AF2142MC-3, AF2142MCP-D4, AF2140MB, AF2140MB-PW, AF2140MBP, AF1142OB, AF2100MB; 5. AirFlow Small Adult Resuscitator REF #s: AF5140MC-D6, AF5140MB-M5, AF5100MB-D5, AF5142MBP-M5, AF5140MBPW-D5, AF5140MBPWTD5, AF5140MBP-D5, AF5140MBP-D6, AF5140MBPW- M5, AF5140MBP-M5, AFN5140MB, AF5140MB-OT, AF5140MB-T, AFD5140MB-T, AF5140MB-K, AF5140MBS-R, AF5140MBS-P, AF5140MB-PT, AF5140MB-ST, AF5140MCP-K, AF5100MB-PW, AF5102MB-N, AF5140MBS-M5. 6. Ventlab, LLC Resuscitation Kit REF # MC1000. | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. | Class II | Open, Classified | |
| Z-1020-2023 | AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405 | There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter. | Class II | Open, Classified | |
| Z-1019-2023 | Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405 | There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter. | Class II | Open, Classified | |
| Z-1779-2022 | Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 | The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle. | Class II | Terminated | |
| Z-2158-2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126P | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | Class II | Terminated | |
| Z-2157-2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | Class II | Terminated | |
| Z-2156-2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE AND 7 FT. OXYGEN TUBING, REF CPRM1126FP | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | Class II | Terminated | |
| Z-2155-2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH LARGE ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126FL | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | Class II | Terminated | |
| Z-2154-2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1126F | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | Class II | Terminated | |
| Z-2153-2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126C | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | Class II | Terminated | |
| Z-2152-2018 | MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126 | There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient. | Class II | Terminated |
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