AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic ma
FDA device recall Z-1768-2013 · posted 2013-07-22 · Terminated
Recall details
- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- Blood blushing/leaking from the surface of the graft after implantation
- Action taken
- LeMaitre Vascular, Inc.sent an Urgent Field Safety Notice daed June 19, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and return the affected device to MeMaitre Vascular which they will replace with a new unit. Customers with questions were instructed to call 781-221-2266, ext. 183. For questions regarding this recall call 781-425-1670, ext 108.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MAL
- Quantity affected
- 1 unit
- Distribution
- Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
- Date initiated
- 2013-06-17
- Date posted
- 2013-07-22
- Date terminated
- 2016-08-15
- Location
- Burlington, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALBOGRAFT VASCULAR PROSTHESIS (K103080) | LeMaitre Vascular, Inc. | 2011-01-19 |
| ALBOGRAFT VASCULAR PROSTHESIS (K093231) | LeMaitre Vascular, Inc. | 2010-01-14 |