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.
FDA Recall Z-0361-2016 · Posted 2015-12-02
Recalling FirmQuest Medical, Inc.
Recall StatusTerminated
Product CodeDTR
Date Initiated2015-10-28
Date Terminated2016-11-17
Product Quantity18,761 units
Reason for Recall
The products have been found to intermittently exhibit a seal failure during use.
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
Distributed US (nationwide) and the countries of Canada, Japan, Saudi Arabia, Kuwait, South Africa, Switzerland, France, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.