Device product
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Z-0533-2025
Product summary
- Event
- Event 95638
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 360 kits
- Official record key
device-enforcement:Z-0533-2025
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 DYNJ59194A - Lot numbers 24DLA916, exp. 12/31/2025; and 24BLA030, exp. 11/30/2025; UDI-DI each 10193489573480, UDI-DI case 40193489573481; and (2) REF DYNJ904220F - Lot number 24DLA070, exp. 11/30/2024, UDI-DI each 10195327362300, UDI-DI case 40195327362301.
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.