GEM Neurotube recall
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
Why was GEM Neurotube recalled?
The product is brittle and potentially crumbling upon handling or when being removed from its package.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023
- Product
- GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 169 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France
- Recall date
- May 3, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)