Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
FDA Recall Z-2075-2010 · Posted 2010-07-22
Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2010-06-18
Date Terminated2010-07-21
Product Quantity1 unit
Reason for Recall
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.
Firm Action
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.
Root Cause
PMA
Distribution Pattern
CA, PA, TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.