Joint Injection Tray Catalog Number: 8561R1
Check against the official notice below — it lists the full affected range.
Busse Hospital Disposables, Inc. is recalling its Joint Injection Tray with catalog number 8561R1 distributed nationwide. The recall affects 480 units across six lot numbers (2031105, 2130068, 2130167, 2130508, 2130862, and 2131115). The tray contains swab or swabstick drug products manufactured by Professional Disposables International (PDI) that are being recalled due to uncertainty about whether the test methods used during manufacturing were properly validated.
The source document does not specify what action affected consumers 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: 480 units Lot/code info: Lot Numbers: Lot 2031105 2130068 2130167 2130508 2130862 2131115 UDI: 00849233016712
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.