FDAMarch 21, 2016device
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.
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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