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.
Reported: December 9, 2015 Initiated: October 28, 2015 #Z-0361-2016
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.
Details
- Recalling Firm
- Quest Medical, Inc.
- Units Affected
- 18,761 units
- Distribution
- Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
- Location
- Allen, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Quest Medical, Inc.. Units affected: 18,761 units.
Why was this product recalled? ▼
The products have been found to intermittently exhibit a seal failure during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2015. Severity: Moderate. Recall number: Z-0361-2016.
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