Busse Hospital Disposables
Also registered as Busse Hosipital Disposables, Busse Hospital Disposables, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 2433012
- Devices
- 37
- Registrations
- FDA
- FDA recalls
- 665 ongoing
What Busse Hospital Disposables makes
Busse Hospital Disposables manufactures single-use medical devices for procedural and diagnostic applications, including epidural catheter kits for spinal anesthesia, bone marrow biopsy/aspiration needles with acquisition cannulas, extension sets for intravenous or catheter lines, and urethral catheters for urinary drainage.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for hospital and clinical use in the United States.
Catalogue
Search and filter all 37 devicesCompany details
- FDA FEI number
- 2433012
- Address
- 75 ARKAY DR., HAUPPAUGE, NY, 11788
FDA recalls
FDA recall records list 66 recalls initiated by BUSSE HOSPITAL DISPOSABLES, the earliest on 2004-04-13 and the most recent on 2023-11-30. By recorded status: 5 ongoing and 61 terminated. The reasons filed fall into these groups: sterility or contamination and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 60
- 2023 3
- 2024 0
- 2025 0
- 2026 0
2023
- 30 Nov 2023 Z-0592-2024 Class I Ongoing 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.
- 30 Nov 2023 Z-0593-2024 Class I Ongoing 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.
- 30 Nov 2023 Z-0594-2024 Class I Ongoing 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.
2022
- 21 Oct 2022 Z-0325-2023 Class II Ongoing 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
- 21 Oct 2022 Z-0326-2023 Class II Ongoing 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
- 22 Feb 2022 Z-1147-2022 Class II Terminated 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
- 22 Feb 2022 Z-1148-2022 Class II Terminated 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
- 22 Feb 2022 Z-1149-2022 Class II Terminated 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
- 22 Feb 2022 Z-1150-2022 Class II Terminated 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
- 22 Feb 2022 Z-1151-2022 Class II Terminated 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
Show the 25 most recent of 66 recalls
2022
- 22 Feb 2022 Z-1152-2022 Class II Terminated 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
- 22 Feb 2022 Z-1153-2022 Class II Terminated 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
- 22 Feb 2022 Z-1154-2022 Class II Terminated 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
- 22 Feb 2022 Z-1155-2022 Class II Terminated 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
- 22 Feb 2022 Z-1156-2022 Class II Terminated 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
- 22 Feb 2022 Z-1157-2022 Class II Terminated 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
- 22 Feb 2022 Z-1158-2022 Class II Terminated 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
- 22 Feb 2022 Z-1159-2022 Class II Terminated 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
- 22 Feb 2022 Z-1160-2022 Class II Terminated 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
- 22 Feb 2022 Z-1161-2022 Class II Terminated 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
- 22 Feb 2022 Z-1162-2022 Class II Terminated 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
- 22 Feb 2022 Z-1163-2022 Class II Terminated 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
- 22 Feb 2022 Z-1164-2022 Class II Terminated 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
- 22 Feb 2022 Z-1165-2022 Class II Terminated 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
- 22 Feb 2022 Z-1166-2022 Class II Terminated 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
Frequently asked questions
How many devices does BUSSE HOSPITAL DISPOSABLES have in the registry?
The registry currently lists 37 devices for BUSSE HOSPITAL DISPOSABLES. Devices recorded under merged duplicate company entries are counted once.
Which registries list BUSSE HOSPITAL DISPOSABLES's devices?
Among its 37 most recently registered devices, BUSSE HOSPITAL DISPOSABLES has devices listed in FDA 510(k) (37 devices).
What risk classes do BUSSE HOSPITAL DISPOSABLES's devices fall under?
Among its 37 most recently registered devices, the classes recorded for BUSSE HOSPITAL DISPOSABLES's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for BUSSE HOSPITAL DISPOSABLES?
FDA recall records list 66 recalls initiated by BUSSE HOSPITAL DISPOSABLES, the most recent initiated on 30 Nov 2023. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from BUSSE HOSPITAL DISPOSABLES in the registry?
The most recently registered devices listed for BUSSE HOSPITAL DISPOSABLES include BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES, DRESSING CHANGE TRAY, BUSSE EPIDURAL CATHETER KIT and INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE.