Device product
Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C
Z-2432-2026
Product summary
- Event
- Event 98951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,654 kits total
- Official record key
device-enforcement:Z-2432-2026
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: DYNJ904305J UDI-DI 10198459268151 lot 25KBT972 DYNJ69533C UDI-DI 10198459524097 lot 26BBC483
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.