FDA Medical Device Recalls (openFDA)
Busse Hospital Disposables, Inc.: Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
- Recall number
- Z-0326-2023
- Recalling firm
- Busse Hospital Disposables, Inc.
- Product
- Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1
- Status
- Open, Classified
- Initiated
- 2022-10-21
- Posted
- 2022-11-29
- Terminated
- not on file
- Reason
- 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
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 40 cases
- Distribution
- TX
- Lot, serial or model codes
- UDI-DI: (01) 00849233016705 Lot Number: 2230458
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGJ
- Firm FEI
- 2433012
- Firm city
- Hauppauge
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28