Device product
Laparotomy Pack Latex Free, part number 007725-7. 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.
Z-1869-2016
Product summary
- Event
- Event 73743
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-1869-2016
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 55689, 55263, and 57680
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.