"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling its 3.2MM Pellet Insertion Tray with Medium Gloves (Catalog Number B1351) because the kits contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). These drug products are subject to recall due to uncertainty about whether the test methods used during manufacturing were adequately validated. The recall affects 120 units distributed nationwide, specifically those with lot numbers 2110082, 2110174, 2110254, and 2110221, which can be identified by UDI 00849233004733.
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: 120 units Lot/code info: Lot Numbers: 2110082 2110174 2110254 2110221 UDI: 00849233004733
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.