Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric
FDA device recall Z-1593-2011 · posted 2011-03-07 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular, LLC
- Reason for recall
- One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.
- Action taken
- The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet. If you have any questions, call the Manager, Regulator Affairs at 973-709-7487.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSY
- Quantity affected
- one unit
- Distribution
- Nationwide distribution: SC only.
- Date initiated
- 2010-12-07
- Date posted
- 2011-03-07
- Date terminated
- 2012-09-12
- Location
- Wayne, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH (K962342) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-09-10 |