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FDANovember 27, 2018device

Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to inter...

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

The hazard

Potential compromise of product sterility due to breach of sterile barrier.

What to do

FDA enforcement status: Terminated

Brands named

medical actionmedical

UPCs

1080916000011350809160000111

Recall history

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

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Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to inter... — Recall Details · AllClear