Quest Myocardial Protection System (MPS) Arrest/Additive… recallZ-1037-03 · Quest Medical, Inc · initiated May 23, 2003
Terminated All recalls posted in July 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Quest Medical, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
FDA root cause category: Other
What the company is doing
The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.
Recall details
- Recall number
- Z-1037-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 23, 2003
- Posted by the FDA
- Jul 22, 2003
- Recalling firm
- Quest Medical, Inc
- Quantity
- 2158 devices
- Product code
- DWF
- FDA submissions
- K953838
- 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
Product description
Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
4 devices cleared under K953838 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MPS 5001102Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass42 reports
- MPS 5001102-ASQuest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass7 reports
- MPS Console 5001000Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass4 reports
- Delivery Set 16C w/ AA 35cm Line 5161102Quest Medical Inc · Heat-Exchanger, Cardiopulmonary Bypass1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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