Single Shot Epidural Tray Catalog 1292
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling its Single Shot Epidural Tray Catalog 1292, which contains swab and swabstick drug products manufactured by Professional Disposables International (PDI). The recall was issued because there is uncertainty about whether the test methods used to manufacture these drug products were adequately validated. A total of 60 units were distributed nationwide, and the affected products are identified by lot numbers 2130282, 2130576, and 2131060, with UDI 00849233003644.
The source document does not specify what consumers or healthcare facilities 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: 60 units Lot/code info: Lot Numbers: 2130282 2130576 2131060 UDI: 00849233003644
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.