SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling SS 4.5MM Pellet Insertion Trays with Large Gloves (Catalog Number B1363R1) because these convenience kits contain swab or swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to a drug recall. The issue stems from uncertainty about whether the validation of the test methods used to manufacture these drug products was adequate. The recall affects 60 units distributed nationwide, specifically those with Lot Numbers 2110127 or 2110269, which can be identified by UDI 00849233006515.
The source document does not specify a remedy or any recommended actions for consumers who have obtained 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: 60 units Lot/code info: Lot Numbers: 2110127 2110269 UDI: 00849233006515
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.