Quest Myocardial Protection System (MPS) Arrest/Additive Cassettes
FDA device recall Z-1037-03 · posted 2003-07-22 · Terminated
Recall details
- Recalling firm
- Quest Medical, Inc
- Reason for recall
- Cassettes leak causing a delay of administration of cardioplegia solutions to the heart during open heart surgery.
- Action taken
- The firm sent letters via fax to consignees on 5/23/2003, 5/28/2003, and 5/29/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 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
- Date initiated
- 2003-05-23
- Date posted
- 2003-07-22
- Date terminated
- 2004-02-18
- Location
- Allen, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MYOCARDIAL PROTECTION SYSTEM (K953838) | Quest Medical, Inc. | 1996-03-06 |