—#92730

Product

Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K082344
Affected lot / code info: Serial number: 12K01077.

Why it was recalled

Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5.

Root cause (FDA determination)

PMA

Action the firm took

The two customers who had received the suspect device accessories were identified and were contacted by letter on 6/18/2010. They were told to immediately discontinue use of the accessories and arrange for return of the products. They were also told that they could continue to use the CD5 Machine without the recalled accessories. A Product Recall Response Form was to completed by each consignee. Questions are directed to the firm at 800-221-7943.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004

Distribution

Distribution pattern: CA, PA, TN.

Timeline

Recall initiated: 2010-06-18
Posted by FDA: 2010-07-22
Terminated: 2010-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92730. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.