—#96450

Product

Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

FDA product code: DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K962342
Affected lot / code info: 510 k - K962342, Product Code/UP #M00202019579P0; Batch #25018564; Exp Date 7/31/2005

Why it was recalled

One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Nationwide distribution: SC only.

Timeline

Recall initiated: 2010-12-07
Posted by FDA: 2011-03-07
Terminated: 2012-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96450. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.