FDA Device

Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.

Hazard

Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size.

What You Should Do

Remedy

All consignees were contacted by telephone on 05/09/2003, followed by a letter.

Products

Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt.
Brand
Cobe Cardiovascular, Inc
UPC
Catalog # 027819201, Lot Number 0304300106.

Units Affected

60 units