dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Cobe Cardiovascular, Inc.
This recall has been terminated (originally issued September 9, 2006).
- Company
- Cobe Cardiovascular, Inc
- Recall Initiated
- August 4, 2006
- Posted
- September 9, 2006
- Terminated
- December 28, 2011
- Recall Number
- Z-1489-06
- Quantity
- 8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
- Firm Location
- Arvada, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
Distribution
Nationwide, including VA facilities in CA and OH
Lot / Code Info
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.
Root Cause
Other
Action Taken
Consignees were notified by telephone and e-mail on 08/04/2006.
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