FDA-Device2019-01-02Class II
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.
Medical Action Industries Inc
Hazard
Potential compromise of product sterility due to breach of sterile barrier.
Sold states
Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
Affected count
13 cases (2,600 sponges)
Manufactured in
25 Heywood Rd, Arden, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0681-2019Don't want to check this manually?
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