Z-0326-2023 Class II Ongoing
FDA device recall Z-0326-2023 was initiated by Busse Hospital Disposables, Inc. on October 21, 2022 and is designated Class II. Reason for recall: Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable The recall status is ongoing. Affected quantity: 40 cases.
Recall Details
- Product Type
- Devices
- Report Date
- December 7, 2022
- Initiation Date
- October 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 cases
Product Description
Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
Reason for Recall
Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable
Distribution Pattern
TX
Code Information
UDI-DI: (01) 00849233016705 Lot Number: 2230458