I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling 2,475 I.V. Start Kits with Tegaderm Dressing and Catheter Securement (Prevantics Catalog Number 822) that were distributed nationwide. The kits contain swab or swabstick products manufactured by Professional Disposables International (PDI) that are subject to recall due to uncertainty about whether the test methods used to manufacture these drug products were adequately validated. The affected lot numbers are 2020514, 2020525, 2020734, 2120255, 2120304, 2120325, and 2120439.
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: 2475 Lot/code info: Lot Numbers: 2020514 2020525 2020734 2120255 2120304 2120325 2120439 UDI: 00849233010017
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.