Reported May 3, 2023 · Ongoing

GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for…

Baxter Healthcare Corporation

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: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube
  • Product Codes
    • a) 5311-01240-010
    • b) 5311-01240-012
    • for peripheral nerve repair
Lot codes and dates
    • a) 5311-01240-010
    • Lot Number 19012112
    • exp. 12/31/2023
    • b) 5311-01240-012
    • Lot Number 19012112
    • exp. 12/31/2023
Amount recalled
169 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

The product is brittle and potentially crumbling upon handling or when being removed from its package.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:44 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.