Device product
Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L.
Z-1868-2016
Product summary
- Event
- Event 73743
- Status
- Terminated
- Classification
- Class II
- Quantity
- 386 units
- Official record key
device-enforcement:Z-1868-2016
Official wording
Reason: These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
Code information: Lot: 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, and 75545.
Distribution pattern: Nationwide distribution to Louisiana and Montana.
Derived failure modes
-
Unknown
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.