Device product
Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L
Z-2447-2026
Product summary
- Event
- Event 98951
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 49,654 kits total
- Official record key
device-enforcement:Z-2447-2026
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: UDI-DI 10195327024369 Lot 25LMJ031
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.