FDA-Device2016-06-08Class II
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.
Windstone Medical Packaging, Inc.
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.
Sold states
Nationwide distribution to Louisiana and Montana.
Affected count
386 units
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1868-2016Don't want to check this manually?
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