dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, 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-1488-06
- 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-WS55C, Lot numbers: 0604030062, 0605310137-COBE Product Code WS125C, Lot Numbers: 0602170043, 0603030050, 0603170057, 0603270019, 0604210104, 0605310135, 0606200074, 0606280029-COBE Product Code WS225C Lot Numbers: 0602100031, 0602170037, 0602240025, 0603030052, 0603100018, 0603270020, 0604070034, 0604130049, 0605030155, 0606200075, 0607200058.
Root Cause
Other
Action Taken
Consignees were notified by telephone and e-mail on 08/04/2006.
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