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Terminated

Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes

FDA Recall Z-1037-03 · Posted 2003-07-22

Recalling FirmQuest Medical, Inc
Recall StatusTerminated
Product CodeDWF
Date Initiated2003-05-23
Date Terminated2004-02-18
Product Quantity2158 devices

Reason for Recall

Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.

Firm Action

The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953838MYOCARDIAL PROTECTION SYSTEMQuest Medical, Inc. · 1996-03-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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