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FDAMarch 21, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

windstone medical packagingwindstonewindstone medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear