FDA Medical Device Recalls (openFDA)
Sorin Group USA, Inc.: Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
- Recall number
- Z-1087-2010
- Recalling firm
- Sorin Group USA, Inc.
- Product
- Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
- Status
- Terminated
- Initiated
- 2009-12-30
- Posted
- 2010-03-12
- Terminated
- 2010-03-15
- Reason
- Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility.
- Root cause
- Packaging process control
- Action
- Customers were notified by letter on December 30, 2009 and asked to examine all inventory for seal voids and arrange for return if any were found defective. Examination instructions were included. The two distributors were given the same instructions and were told to share all the information with any of their customers.
- Quantity
- 2 units
- Distribution
- AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
- Lot, serial or model codes
- Lot Number: 0933600001
- 510(k) numbers
- ["K881330"]
- 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