Lumbar Tray Catalog 1091
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Lumbar Tray Catalog 1091 Convenience kits distributed nationwide. These kits contain swab or swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to recall due to uncertainty about whether the test methods used in manufacturing were adequately validated. The recall affects 330 units with the following lot numbers: 2030899, 2130011, 2130214, 2130789, 2130798, 2130898, and 2131135. The product has UDI 00849233000247.
The source document does not specify what actions consumers or healthcare facilities should take 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: 330 units Lot/code info: Lot Numbers: 2030899 2130011 2130214 2130789 2130798 2130898 2131135 UDI: 00849233000247
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.