Skip to content
Recall Observatory FDA recall evidence

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

March 21, 2016

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
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

    reason.no_named_rule · v1.0.0

    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.