Bone Marrow Biopsy Tray Catalog Number: 8917R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Bone Marrow Biopsy Tray Catalog Number 8917R1 nationwide. The recall affects 80 units distributed across specific lot numbers (2020741, 2120119, 2120342, and 2120630). These kits contain swab or swabstick products manufactured by Professional Disposables International (PDI) that are being recalled due to concerns about whether the test methods used during manufacturing were properly validated.
The recall notice does not specify what consumers or healthcare facilities should do with affected products.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: Nationwide Quantity: 80 units Lot/code info: Lot Numbers: 2020741 2120119 2120119 2120342 2120630 UDI: 00849233002012
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.