FDA Medical Device Recalls (openFDA)
Cobe Cardiovascular, Inc: dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Cobe Cardiovascular, Inc.
- Recall number
- Z-1489-06
- Recalling firm
- Cobe Cardiovascular, Inc
- Product
- dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Cobe Cardiovascular, Inc.
- Status
- Terminated
- Initiated
- 2006-08-04
- Posted
- 2006-09-09
- Terminated
- 2011-12-28
- Reason
- Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
- Root cause
- Other
- Action
- Consignees were notified by telephone and e-mail on 08/04/2006.
- Quantity
- 8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
- Distribution
- Nationwide, including VA facilities in CA and OH
- Lot, serial or model codes
- COBE Product Code WS55E, Lot numbers: 0603030047, 0604030059, 0605170017-COBE Product Code-WS125E, Lot Numbers: 0602170041, 0603030051, 0604210103-COBE Product Code WS175E, Lot Numbers: 0601180099, 0604030060-COBE Product Code-WS225E, Lot Numbers: 0601180100, 0602170042, 0603030049, 0603170058, 0604030061, 0604070035, 0604130050, 0605230075, 0607200059.
- 510(k) numbers
- ["K020647"]
- PMA numbers
- not on file
- Product code
- CAC
- 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