Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
AVID Medical, Inc. · Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Open FDA's page for this record- Cfres ID
- 222419
- Product res number
- Z-3152-2026
- Event date initiated
- 2026-08-10
- Event date posted
- 2026-09-16
- Recall status
- Open, Classified
- Res event number
- 99758
- Product code
- OGD
- Product description
- Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;
- Code info
- Model/Item Number (Kit): BMCN001-05; UDI-DI: 10809160455128; Kit Lots: 1703122, 1707656, 1708053; Recalled Sodium Chloride Ampule Lot: AB5002;
- Firm FEI number
- 1047429
- Recalling firm
- AVID Medical, Inc.
- Address 1
- 9000 Westmont Dr
- City
- Toano
- State
- VA
- Postal code
- 23168-9351
- Additional info contact
- Marlene Jones 470-280-4277
- Reason for recall
- Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 80 kits
- Distribution pattern
- Domestic: IL, NC, VA, WY;
- 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.
- Harmonized identifiers (openFDA)
- Device name
- Custom Anesthesia Tray
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5120
- Device class
- 2
- Registration number
- 1030451, 1643817, 3004076349, 1061927, 1928237, 1423537, 1047429, 3015173212, 3008552585, 3035642068, 9616088, 3009888344, 1018470, 9611612, 3007329020, 3005012805, 1061124, 3004111573
- FEI number
- 1030451, 1643817, 1000512168, 3001236905, 3004076349, 1928237, 1047429, 3015173212, 3008552585, 3002902735, 3035642068, 3002807847, 1018470, 3009888344, 3007329020, 3005012805, 3000203000, 3004111573
