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

FDA device recall Z-2075-2010 · posted 2010-07-22 · Terminated

Recall details

Recalling firm

Sorin Group USA, Inc.

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.

Action taken

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

Status

Terminated

Product code

DWF

Quantity affected

1 unit

Distribution

CA, PA, TN.

Date initiated

2010-06-18

Date posted

2010-07-22

Date terminated

2010-07-21

Location

Arvada, CO

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