EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight Maquet Cardiovascular LLS, 45 Barbour Pond Dri
FDA device recall Z-0866-2010 · posted 2010-02-26 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, lot # 12633379 were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.
- Action taken
- Recall letters were sent to all US customers on January 20, 2010 by certified mail. Letters for foreign consignees were to be sent as soon as translation was completed. Customer are directed to call the company at 973-709-7515 for more information.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DSY
- Quantity affected
- 18 units
- Distribution
- Product was distributed to hospitals in TX, TN, CT, AR, AZ as well as to Austria and France.
- Date initiated
- 2010-01-20
- Date posted
- 2010-02-26
- Date terminated
- 2010-07-06
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN (K052964) | Boston Scientific Corp | 2006-01-06 |