Single Shot Epidural Tray Catalog Number: 6797R2
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Single Shot Epidural Trays (Catalog Number 6797R2) distributed nationwide. The trays contain swab or swabstick products manufactured by Professional Disposables International that are subject to recall due to concerns about whether the test methods used to manufacture these drug products were adequately validated. A total of 40 units are affected, specifically those with lot numbers 2030835, 2031025, 2031217, or 2130006 (UDI: 00849233014657).
The source does not specify a remedy or what affected consumers should do 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: 40 units Lot/code info: Lot Numbers: 2030835 2031025 2031217 2130006 UDI: 00849233014657
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.