The Recall Desk
HighFDA (Devices)·Z-0681-2019·Announced 2019-01-02

Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise

Medical Action Industries is recalling 2,600 laparotomy sponges because a breach of the sterile barrier may have compromised product sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a potential sterility breach in a medical device used inside the body, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Medical Action Industries Inc is recalling 13 cases (2,600 sponges) of Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles. The recall is due to a potential compromise of product sterility caused by a breach of the sterile barrier.

The affected product is identified by Model Number 403, Lot Number 1806JK305A, and Expiration Date 06/20/2023. The devices were distributed in five U.S. states: Minnesota, Washington, New York, Massachusetts, and Michigan. No product was distributed outside of the United States.

Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structures to control bleeding, absorb fluid, or protect organs from abrasions, drying, or contamination. Users should stop using the affected sponges and contact the manufacturer for instructions on return or replacement.

The recalled product

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
Manufacturer
Medical Action Industries Inc
Category
Medical Device — Surgical Sponges
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Model Number: 403
  • Lot Number: 1806JK305A
  • Expiration Date: 06/20/2023
  • UDI (Pack): 10809160000113
  • UDI (Case): 50809160000111

Distribution

Distributed in 5 states:

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