Device product
(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
Z-0532-2025
Product summary
- Event
- Event 95638
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 408 kits
- Official record key
device-enforcement:Z-0532-2025
Official wording
Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Code information: (1) REF CDS840132O - Lot number 24BBF701, exp. 10/31/2024, UDI-DI each 10195327245276, UDI-DI case 40195327245277; (2) REF DYNJ903016G - Lot numbers 24DBP801, exp. 8/31/2025; and 24CBJ749, exp. 11/30/2024, UDI-DI each - 10195327657154, UDI-DI case - 40195327657155.
Distribution pattern: US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.
Derived failure modes
-
Unknown
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.