4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
Reported: June 8, 2022 Initiated: February 22, 2022 #Z-1186-2022
Product Description
4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
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
Details
- Recalling Firm
- Busse Hospital Disposables, Inc.
- Units Affected
- 30 units
- Distribution
- Nationwide
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362. Recalled by Busse Hospital Disposables, Inc.. Units affected: 30 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2022. Severity: Moderate. Recall number: Z-1186-2022.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11