Recall record at a glance
| Official record | Z-1912-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Vascutek, Ltd. |
| Report date | Jul 8, 2015 |
| Recall initiation date | May 15, 2015 |
| Quantity | 12 |
| Location | Inchinnan, United Kingdom |
Official product description
Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
Why the product was recalled
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Distribution information
Distributed in the state of Michigan (USA), and the countries of United Kingdom, Australia, Poland, and Germany.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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