Device product
BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A
Z-2416-2026
Product summary
- Event
- Event 98951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,654 kits total
- Official record key
device-enforcement:Z-2416-2026
Official wording
Reason: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Code information: DYNJRA2119A UDI-DI 10198459194702 lot 25LBB738 DYNJRA1011A UDI-DI 10888277783614 lots 25KBB849 25LBB734
Distribution pattern: US Nationwide distribution. OUS distribution pending.
Derived failure modes
-
Unknown
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.