Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8
FDA device recall Z-1637-2015 · posted 2015-05-29 · Terminated
Recall details
- Recalling firm
- Synovis Surgical Innovations, Inc.
- Reason for recall
- Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
- Action taken
- The firm, Baxter, sent an "Urgent Product Recall" letter dated 5/2/2015 via USPS overnight delivery to its customers. The letter identified the affected product, problem and actions to be taken. The customers were instructed to immediately discontinue use and segregate the affected product, locate and remove all affected product from your facility and to return it to Baxter. Customers are to contact Baxter Healthcare Center, 888-229-0001, for Service to arrange for return and credit. In addition, the customers were to complete and return the Customer Reply Form by faxing to 224-270-5457 or emailing to fca@baxter.com. If you have any questions, contact Director, Quality at 651-796-7543 or email: heidi_drafall@baxter.com.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DXZ
- Quantity affected
- 3,974
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-05-02
- Date posted
- 2015-05-29
- Date terminated
- 2016-02-18
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASCU-GUARD Peripheral Vascular Patch (K142461) | Synovis Life Technologies, Inc. | 2014-11-25 |