Gelseal Straight Diameter 8mm Length 30cm. Vascular recall
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native…
Why was Gelseal Straight Diameter 8mm Length 30cm. Vascular recalled?
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Product Code 433008, Batch 301509/02, Serial Numbers 0001515204, 0001515205, 0001515206, 0001515207, 0001515208, 0001515209, 0001515210, 0001515211, 0001515212, 0001515213, 0001515214, 0001515215
- Product
- Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native…
- Recalling firm
- Vascutek, Ltd.
- Quantity
- 12
- Distribution
- Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
- Recall date
- July 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)