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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 8, 2019 · Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.