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Recall Observatory FDA recall evidence

Device product

General Surgery Pack, part number 006880-3. 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-1870-2016

March 21, 2016

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 73743
Status
Terminated
Classification
Class II
Quantity
170 units
Official record key
device-enforcement:Z-1870-2016

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 56402, 57255, 60542, and 61506

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.