3.2MM Pellet Insertion Tray Catalog Number: B7345R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling its 3.2MM Pellet Insertion Tray (Catalog Number B7345R1) because the kits contain swab and swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to a separate drug recall. The issue involves uncertainty about whether the test methods used to manufacture these drug products were adequately validated. This recall affects 250 units distributed nationwide across multiple lot numbers: 2031074, 2031227, 2130194, 2130535, and 2130783.
The source document does not specify what actions affected consumers should take regarding this recall.
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: 250 units Lot/code info: Lot Numbers: 2031074 2031227 2130194 2130535 2130783 UDI: 00849233016996
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.