medical Class II Updated 2019-01-02

Medical Action Industries Inc recalls Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 1

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Affected States: MN, WA, NY, MA, MI
Lot/Code Info: Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111
View official government recall

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