CVC Dressing Change Kit Catalog Number: 2491R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling its CVC Dressing Change Kit (Catalog Number 2491R1) nationwide. The kits 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 during manufacturing were adequately validated. A total of 200 units are affected, specifically those with lot numbers 2020472, 2020519, 2020651, or 2020759.
The recall notice does not specify what actions affected consumers or healthcare facilities 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: 200 units Lot/code info: Lot Numbers: 2020472 2020519 2020651 2020759 UDI: 00849233004481
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.