FDA Medical Device Recalls (openFDA)
Sorin Group USA, Inc.: Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
- Recall number
- Z-2075-2010
- Recalling firm
- Sorin Group USA, Inc.
- Product
- Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
- Status
- Terminated
- Initiated
- 2010-06-18
- Posted
- 2010-07-22
- Terminated
- 2010-07-21
- Reason
- 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
- PMA
- 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.
- Quantity
- 1 unit
- Distribution
- CA, PA, TN.
- Lot, serial or model codes
- Serial number: 12K01077.
- 510(k) numbers
- ["K082344"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28