Recall Z-0325-2023
Busse Hospital Disposables, Inc. · initiated October 21, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1
Codes / lots: UDI-DI: (01)00849233016712 Lot Number: 2230276
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
FDA-determined cause: Device Design
Action taken
Busse issued Product Recall Notification Letter dated 10/20/22 to Distributor; End User via Email on 10/21/2022 and Certified Mail on 10/24/2022 Letter states reason for recall, health risk and action to take: 1. Immediately check your inventory for the lots listed above. 2. Do not use the drape included in the product with the lot number(s) listed above. 3. Complete the enclosed Response Form within the next 10 days and return via email to csabillon@busseinc.com even if you have no affected product on hand. a. If you do have product in stock, destroy the drape following your facility policy.
Details
- Recall number
- Z-0325-2023
- Initiated
- October 21, 2022
- Posted by FDA
- November 29, 2022
- Product code
- OGJ – Nerve Block Tray
- Quantity
- 80 cases
- Distribution
- TX
- Recalling firm
- Busse Hospital Disposables, Inc., Hauppauge, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0326-2023 Class II | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive component is… | 10/21/2022Open, Classified |