4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling 4.5 MM Pellet Insertion Trays (Catalog Number B8121R1) distributed nationwide. The trays contain swab or swabstick products manufactured by Professional Disposables International (PDI) that are subject to recall because there is uncertainty about whether the test methods used to manufacture these drug products were adequately validated. A total of 99 units are affected, specifically those with Lot Numbers 2031076 or 2130823.
The source document does not specify what actions affected consumers should take in response to 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: 99 units Lot/code info: Lot Numbers: 2031076 2130823 UDI:00849233017306
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.