Core Biopsy Tray Catalog Number: 8673R4
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables is recalling its Core Biopsy Tray (catalog number 8673R4) because the kits contain swab and swabstick products manufactured by Professional Disposables International (PDI) that are subject to a separate drug recall. The issue stems from uncertainty about whether the test methods used to manufacture these swab products were adequately validated. A total of 285 units were distributed nationwide, identified by lot numbers 2031043, 2130119, 2130382, 2130830, and 2130997.
The recall notice does not specify what consumers or healthcare facilities should do with affected products.
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: 285 units Lot/code info: Lot Numbers: 2031043 2130119 2130382 2130830 2130997 UDI: 00849233017092
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.