SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling SS 3.5mm Pellet Insertion Trays with large gloves (Catalog Number B1352R1) nationwide. The recall affects 120 units distributed under specific lot numbers: 2110100, 2110083, 2110226, and 2110262. These convenience kits contain swab or swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to recall due to uncertainty about whether the test methods used to manufacture the drug products were adequately validated.
The recall notice does not specify a remedy or recommended action for consumers who have this product.
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: 2110100 2110083 2110226 2110262 UDI: 00849233004719
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.