FDA Recall
Terminated
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.
Recall: Z-0361-2016
·
Initiated October 28, 2015
Recall
- Recall Number
- Z-0361-2016
- Event Number
- 72524
- Firm
- Quest Medical, Inc.
- FEI Number
- 3001665800
- Product Code
- DTR
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- October 28, 2015
- Posted
- December 2, 2015
- Terminated
- November 17, 2016
- Address
- 1 Allentown Pkwy, Allen, TX, 75002-4206
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
The products have been found to intermittently exhibit a seal failure during use.
Action
The recalling firm issued a press release on 10/28/2015. The press release was posted on FDA website on 10/29/2015. The recalling firm emailed affected consignees on 10/28/15 and sent out recall letters via USPS beginning 10/30/15.
Distribution
Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
Quantity
18,761 units