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,…

Recall date

November 27, 2018

Source

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

Recall number

Z-0681-2019

FDA classification

Class II

Brand / firm

Medical Action Industries Inc

Sold / distributed

Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.

Why it was recalled

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

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 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.