Single Shot Epidural Tray Catalog 1165
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables' Single Shot Epidural Tray (Catalog 1165) is being recalled because the kits contain swab or swabstick drug 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 drug products were adequately validated. The recalled product was distributed nationwide, with 20 units affected across specific lot numbers: 2130290 and 2131184. The UDI code associated with this product is 00849233006485.
The source document does not specify what actions affected consumers should take regarding 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: 20 units Lot/code info: Lot Numbers: 2130290 2131184 UDI: 00849233006485
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.