Universal Tray Catalog 1567
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling its Convenience kits nationwide due to swab and swabstick drug products manufactured by Professional Disposables International (PDI) contained within them. The products are being recalled because there is uncertainty about whether the test methods used to validate the manufacturing process were adequate.
The recall affects 96 units distributed nationwide. The affected lot numbers are 2130419, 2130880, and 2131187, with UDI 00849233005655. The source document does not specify a remedy or instructions for affected consumers.
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: 96 units Lot/code info: Lot Numbers: 2130419 2130880 2131187 UDI: 00849233005655
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.