FDA Medical Device Recalls (openFDA)
AVID Medical, Inc.: Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
- Recall number
- Z-3152-2026
- Recalling firm
- AVID Medical, Inc.
- Product
- Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
- Status
- Open, Classified
- Initiated
- 2026-08-10
- Posted
- 2026-09-16
- Terminated
- not on file
- Reason
- Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Root cause
- Nonconforming Material/Component
- Action
- On August 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, Segregate, and Quarantine all impacted kits listed. 2. Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative. 3. REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use. 4. Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6. Complete the attached Recall Response Form and return.
- Quantity
- 80 kits
- Distribution
- Domestic: IL, NC, VA, WY;
- Lot, serial or model codes
- Model/Item Number (Kit): BMCN001-05; UDI-DI: 10809160455128; Kit Lots: 1703122, 1707656, 1708053; Recalled Sodium Chloride Ampule Lot: AB5002;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGD
- Firm FEI
- 1047429
- Firm city
- Toano
- Firm state
- VA
- 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