Pump Refill Kit Catalog Number: 7347R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling its Pump Refill Kit (Catalog Number 7347R1) nationwide. The recall affects 40 units containing swab and swabstick drug products manufactured by Professional Disposables International (PDI). The recall was issued because there is uncertainty about whether the test methods used to manufacture these drug products were adequately validated. The affected lots are 2030921 and 2130507, which can be identified using UDI 00849233009363.
Consumers who have purchased this product should be aware of this recall. The recall notice does not specify what actions affected consumers should take or how to obtain a remedy.
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: 40 units Lot/code info: Lot Numbers: 2030921 2130507 UDI: 00849233009363
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.