Z-1037-03

Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes

Name: Z-1037-03 Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
Creator: Quest Medical, Inc
Published: 2003-05-23
License: https://open.fda.gov/license/

Quest Medical, Inc / initiated 2003-05-23 / Terminated

FDA source

Quest Medical, Inc began a recall of Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes on 2003-05-23. The reason FDA records is "Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1037-03
Status: Terminated
Initiated: 2003-05-23
Posted: 2003-07-22
Terminated: 2004-02-18
Recalling firm: Quest Medical, Inc
Product: Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
FDA root cause: Other
Action: The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.
Quantity in commerce: 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
Product codes and lots: 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

Product code DWF

K953838Class IIMyocardial Protection SystemQuest Medical, Inc. / cleared 1996-03-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)