Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
- Company
- Quest Medical, Inc.
- Recall Initiated
- May 23, 2003
- Posted
- July 22, 2003
- Terminated
- February 18, 2004
- Recall Number
- Z-1037-03
- Quantity
- 2158 devices
- Firm Location
- Allen, TX
Reason for Recall
Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
Distribution
CA, PA, FL, ME, TX, MA, OH, ON, NM, WA, MO, GA, SC, MS, IL, LA, NC, NJ, MA, AK, TN, MT, WI, IN, WV, NE, Japan, Canada
Lot / Code Info
Catalog Number: 5001102 Lot numbers; 20823.R10; 20853.S01; and 20863.S04 Catalog Number 5001104, lot number 20706.S09 Lots manufactured but not distributed: Catalog Number 6001101, lot 20639.R10 Catalog Number 7001102, lot 20638.R10
Root Cause
Other
Action Taken
The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.
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