Cervical Tray Catalog 1089
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling Convenience kits with Catalog Number 1089 that contain swab or swabstick drug products manufactured by Professional Disposables International (PDI). The recall affects 80 kits distributed nationwide due to uncertainty about whether the test methods used to manufacture these drug products were adequately validated.
The affected products are identified by the following lot numbers: 2030899, 2130011, 2130214, 2130789, 2130798, 2130898, and 2131135. The UDI (Unique Device Identifier) is 00849233000414. The source document does not specify what action 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: 80 Lot/code info: Lot Numbers: 2030899 2130011 2130214 2130789 2130798 2130898 2131135 UDI: 00849233000414
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.