Recall Z-0361-2016— Quest Medical, Inc.
Class II · Terminated
Class II FDA medical device recall by Quest Medical, Inc., initiated 2015-10-28, terminated 2016-11-17. It names one FDA 510(k) clearance: K953838. Product: Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.. Reason: The products have been found to intermittently exhibit a seal failure during use..
- Recalling firm
- Quest Medical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-10-28
- Terminated
- 2016-11-17
- Firm location
- Allen, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
Reason for recall
The products have been found to intermittently exhibit a seal failure during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.