Procedure Tray Catalog 1065
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Procedure Tray Catalog 1065 Busse Convenience kits that contain swab or swabstick drug products manufactured by Professional Disposables International (PDI). The recall affects 46 units distributed nationwide due to uncertainty about whether the test methods used to manufacture these drug products were properly validated.
The affected lots are numbered 2030699 and 2130342, with UDI 00849233003354. The source document does not specify what consumers or healthcare facilities should do if they have purchased 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: 46 units Lot/code info: Lot Numbers: 2030699 2130342 UDI: 00849233003354
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.