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) 5311-01240-010b) 5311-01240-012for peripheral nerve repair
- Lot codes and dates
a) 5311-01240-010Lot Number 19012112exp. 12/31/2023b) 5311-01240-012Lot Number 19012112exp. 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.
Want the full recall guide?
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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