Reported Jan 2, 2019 · Terminated
Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack,…
Medical Action Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medical Action Industries Inc · 25 Heywood Rd · Arden, NC · 28704-9302
Is this the product you have?
- 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 useLaparotomy 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
- Lot codes and dates
- Model Number403
- Lot Number1806JK305A
- Expiration Date06/20/2023
- UDI (Pack)10809160000113
- UDI (Case)50809160000111
- Amount recalled
- 13 cases (2,600 sponges)
Where it was sold
Why it was recalled
Potential compromise of product sterility due to breach of sterile barrier.
This product could cause temporary or reversible health problems — stop using it.
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