Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without han...
FDA Recall #Z-0681-2019 — Class II — November 27, 2018
Product Description
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.
Reason for Recall
Potential compromise of product sterility due to breach of sterile barrier.
Recalling Firm
Medical Action Industries Inc — Arden, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
13 cases (2,600 sponges)
Distribution
Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
Code Information
Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.