Recall Z-1169-2022— Busse Hospital Disposables, Inc.
Class II · Terminated
Class II FDA medical device recall by Busse Hospital Disposables, Inc., initiated 2022-02-22, terminated 2024-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Single Shot Epidural Tray Catalog Number: 6183R1. Reason: 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.
- Recalling firm
- Busse Hospital Disposables, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-02-22
- Terminated
- 2024-04-17
- Firm location
- Hauppauge, NY, United States
Product description
Single Shot Epidural Tray Catalog Number: 6183R1
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.