Sterile Epidural Tray Catalog Number: 6259R2
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Sterile Epidural Tray catalog number 6259R2 distributed nationwide. The recall affects 50 units containing swab and swabstick drug products manufactured by Professional Disposables International (PDI). The products are being recalled because there is uncertainty about whether the test methods used to manufacture these drug products were properly validated.
The affected products have lot numbers 2130839, 2131167, 2131230, and 2131210, with UDI 00849233000278. The source document does not specify what actions 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: 50 units Lot/code info: Lot Numbers: 2130839 2131167 2131230 2131210 UDI: 00849233000278
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.