Female SS 3.5MM Pellet Insertion Tray Catalog Number: B1568
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Female SS 3.5MM Pellet Insertion Trays (Catalog Number B1568) nationwide. These convenience kits contain swab or swabstick drug products manufactured by Professional Disposables International (PDI). The recall was initiated because there is uncertainty about whether the test methods used to manufacture these swab products were properly validated. A total of 100 units are affected, specifically those with Lot Numbers 2130338 and 2130562 (UDI: 00849233005525).
The recall notice does not specify what consumers or healthcare facilities should do if they have this product. Affected parties should contact the manufacturer or their healthcare provider for further guidance on how to proceed.
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: 100 units Lot/code info: Lot Numbers: 2130338 2130562 UDI: 00849233005525
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.