FDA Device

dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc.

Hazard

Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.

What You Should Do

Remedy

Consignees were notified by telephone and e-mail on 08/04/2006.

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Products

dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc.
Brand
Cobe Cardiovascular, Inc
UPC
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.

Units Affected

8,964 wash sets, 1,518 Stat pacs- Recalls Z-1488-1491-06

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