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Medical Action Industries Inc recalls Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 4
Recalled January 2, 2019 · FDA recall Z-0681-2019 · Medical Action Industries
Hazard
Potential compromise of product sterility due to breach of sterile barrier. · FDA Class II
Units
13 cases (2,600 sponges)
Sold at
Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
Description
Potential compromise of product sterility due to breach of sterile barrier.
Product
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 internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.
Manufacturer(s)
Medical Action Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →