FDA-Device2023-05-03Class II
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Baxter Healthcare Corporation
Hazard
The product is brittle and potentially crumbling upon handling or when being removed from its package.
Sold states
Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France
Affected count
169 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1461-2023Don't want to check this manually?
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