Single Shot Epidural Tray - 18G Catalog Number: 8139R2
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Single Shot Epidural Trays (Catalog Number 8139R2) nationwide. These convenience kits contain swab or swabstick products manufactured by Professional Disposables International (PDI) that are subject to a drug recall. The issue involves uncertainty about whether the test methods used to manufacture these swab products were properly validated. A total of 20 units have been distributed, specifically those with lot numbers 2031049 or 2131128.
The recall affects epidural trays distributed across the United States. Consumers who have received this product with the affected lot numbers should be aware of this recall. The source document does not specify what remedy or action affected consumers should take.
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: 20 units Lot/code info: Lot Numbers: 2031049 2131128 UDI: 00849233015890
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.