Busse Hospital Disposables
Hauppauge, NY, US
BUSSE HOSPITAL DISPOSABLES appears in FDA device records in Hauppauge, NY. FDA records list 35 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 76 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Busse Hospital Disposables 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.
- Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposablesenforcement report, recall
510(k) clearance history
FDA records hold 35 510(k) clearances for Busse Hospital Disposables between 1983 and 2015. The busiest year on record is 1995, with 5. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 3 |
| 1990 | 2 |
| 1994 | 2 |
| 1995 | 5 |
| 1996 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141285 | BUSSE EXTENSION SET | FPA | Substantially Equivalent | |
| K120002 | I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE | KNW | Substantially Equivalent | |
| K110883 | J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA | KNW | Substantially Equivalent | |
| K093920 | BUSSE EPIDURAL CATHETER KIT | BSO | Substantially Equivalent | |
| K093909 | BUSSE SURGICAL DRAPES IV | KKX | Substantially Equivalent | |
| K092212 | BUSSE SURGICAL DRAPES III | KKX | Substantially Equivalent | |
| K082297 | BUSSE SURGICAL DRAPE | KKX | Substantially Equivalent | |
| K073222 | MODIFICATION TO:SPECIALTY NEEDLES | BSP | Substantially Equivalent | |
| K070465 | BUSSE EPIDURAL CATHETER | BSO | Substantially Equivalent | |
| K063018 | GLASS LOSS OF RESISTANCE SYRINGE | CAZ | Substantially Equivalent | |
| K061394 | SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) | BSP | Substantially Equivalent | |
| K061570 | I-STYLE BONE MARROW ASPIRATION NEEDLE | KNW | Substantially Equivalent | |
| K052843 | BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE | FMI | Substantially Equivalent | |
| K041464 | BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER | EZD | Substantially Equivalent | |
| K032432 | BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER | FMJ | Substantially Equivalent | |
| K021055 | BUSSE UMBILICAL CORD CLAMP CUTTER | HFW | Substantially Equivalent | |
| K010835 | POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 | HFW | Substantially Equivalent | |
| K963260 | DRESSING CHANGE TRAYS | FMF | Substantially Equivalent | |
| K953019 | HYDROPHILIC FOAM DRESSING | KMF | Substantially Equivalent for Some Indications | |
| K952948 | SALINE DRESSING | FRO | Substantially Equivalent for Some Indications | |
| K952334 | DRESSING CHANGE TRAY | MCY | Substantially Equivalent | |
| K950560 | SALINE SOLUTINE, STERILE | IGE | Substantially Equivalent | |
| K941845 | BUSE STAFF PROTECTION GOWNS AND KITS | FYC | Substantially Equivalent | |
| K940720 | BUSSE ISOLATION AND PROCEDURAL MASKS | FXX | Substantially Equivalent | |
| K935835 | BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES | BYX | Substantially Equivalent | |
| K902297 | BUSSE BAC/SHIELD | BSY | Substantially Equivalent | |
| K900479 | STERILE LACERATION TRAY CAT. #749 | FSM | Substantially Equivalent | |
| K881312 | LAMINARIA | HDY | Substantially Equivalent | |
| K874306 | INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE | LGM | Substantially Equivalent | |
| K875058 | STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407 | BSY | Substantially Equivalent | |
| K874186 | BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE | LDQ | Substantially Equivalent | |
| K863712 | I.V. START KIT, STERILE, DISPOSABLES | LRS | Substantially Equivalent | |
| K861711 | SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLE | GDT | Substantially Equivalent | |
| K843496 | DRAPE SURGICAL UTILITY DRAPE STERILE | KKX | Substantially Equivalent | |
| K830890 | SURGICAL FACE MASK | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2433012 | 2433012 | BUSSE HOSPITAL DISPOSABLES | 75 ARKAY DR., HAUPPAUGE, NY 11788 US | 2026 | and 68 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HGEAmniotome
- CAZAnesthesia Conduction Kit
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- IWOApron, Protective
- FONBag, Drainage, With Adhesive, Ostomy
- KYRBag, Ice
- KMFBandage, Liquid
- FYFCap, Surgical
- BSOCatheter, Conduction, Anesthetic
- GBWCatheter, Peritoneal
- EZDCatheter, Straight
- BSYCatheters, Suction, Tracheobronchial
- LGMChamber, Patient Isolation
- HFWClamp, Umbilical
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- KPLColonic Irrigation System
- FMHContainer, Specimen, Sterile
- FXPCover, Shoe, Operating-Room
- HCYCurette, Uterine
- HDYDilator, Cervical, Hygroscopic-Laminaria
- KKXDrape, Surgical, Antimicrobial
- FRODressing, Wound, Drug
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HTDForceps
- FYCGown, Isolation, Surgical
- KNWInstrument, Biopsy
- HBSInstrument, Clip Forming/Cutting
- KDCInstrument, Surgical, Disposable
- HAOInstrument, Surgical, Non-Powered
- KDDKit, Surgical Instrument, Disposable
- FDELaparoscopy Kit
- FMJManometer, Spinal-Fluid
- FXXMask, Surgical
- GAANeedle, Aspiration And Injection, Disposable
- GCBNeedle, Catheter
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FMINeedle, Hypodermic, Single Lumen
- HHDPad, Menstrual, Unscented
- FTNPlastic Surgery And Accessories Kit
- JNQQualitative Chemical Reactions, Urinary Calculi (Stone)
- HIOSampler, Amniotic Fluid (Amniocentesis Tray)
- JOKScissors, Medical, Disposable
- FPASet, Administration, Intravascular
- IGESolution, Formalin Ammonium Bromide
- GDTStaple, Removable (Skin)
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- FTYTape, Measuring, Rulers And Calipers
- BYZTrap, Sterile Specimen
- FCHTray, Biopsy, Without Biopsy Instruments
- FKGTray, Start/Stop (Including Contents), Dialysis
- FSMTray, Surgical, Instrument
- DRCTrocar
- FBQTrocar, Gastro-Urology
- BYYTube, Aspirating, Flexible, Connecting
- FPKTubing, Fluid Delivery
- BYXTubing, Pressure And Accessories
- ECBUnit, Syringe, Air And/Or Water
- FRGWrap, Sterilization
Recall records
Showing 25 of 76| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0594-2024 | Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death. | Class I | Open, Classified | |
| Z-0593-2024 | Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death. | Class I | Open, Classified | |
| Z-0592-2024 | Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE | Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death. | Class I | Open, Classified | |
| Z-0326-2023 | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable | Class II | Open, Classified | |
| Z-0325-2023 | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable | Class II | Open, Classified | |
| Z-1204-2022 | SS 4.5MM Pellet Insertion Tray Catalog Number: B9807 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1203-2022 | 3.2MM Pellet Insertion Tray Catalog Number: B9743 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1202-2022 | Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1201-2022 | Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1200-2022 | SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1199-2022 | 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1198-2022 | SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1197-2022 | 3.2MM Pellet Insertion Tray Catalog Number: B7345R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1196-2022 | Pellet Insertion Tray Catalog Number: B1654 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1195-2022 | Male SS 4.5MM Pellet Insertion Tray Catalog Number: B1570 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1194-2022 | Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1193-2022 | SS 4.5MM DIAMOND TIP TROCAR WITH MEDIUM GLOVES Catalog Number: B1560 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1192-2022 | SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1191-2022 | SS 3.5MM Diamond Tip Trocar - Medium Gloves Catalog Number: B1555 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1190-2022 | SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1189-2022 | SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1188-2022 | SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1187-2022 | SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1186-2022 | 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated | |
| Z-1185-2022 | 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1360 | Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain