FDA Medical Device Recalls (openFDA)
Quest Medical, Inc: Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
- Recall number
- Z-1037-03
- Recalling firm
- Quest Medical, Inc
- Product
- Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
- Status
- Terminated
- Initiated
- 2003-05-23
- Posted
- 2003-07-22
- Terminated
- 2004-02-18
- Reason
- Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
- Root cause
- Other
- Action
- The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.
- Quantity
- 2158 devices
- 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, serial or model codes
- 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
- 510(k) numbers
- ["K953838"]
- PMA numbers
- not on file
- Product code
- DWF
- Firm FEI
- 3001665800
- Firm city
- Allen
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28