Windstone Medical Packaging, Inc. recalls Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. T…

Recall date

March 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1868-2016

FDA classification

Class II

Brand / firm

Windstone Medical Packaging, Inc.

Sold / distributed

Nationwide distribution to Louisiana and Montana.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.