Myocardial Protection System Recalled Due to Patient Blood Loss
Quest Medical, Inc. has announced a nationwide recall for Myocardial Protection System (MPS) Delivery Sets. The product has been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss.
The firm has received 20 complaints alleging this seal failure which have resulted in 16 instances of patient blood loss during surgery. There have been no reports of patient injuries as a result of the alleged issue to date.
Recalled model numbers include: 5001102, 5001102-AS, and 7001102. For list of the affected lots, see the Food and Drug Administration (FDA) release. The affected product lot information can be identified by product labeling on shipper and individual sterile trays.
The impacted items were manufactured from May 2015 to September 2015 and distributed from June 2015 to September 2015.
Consumers who have the applicable lots of the MPS Delivery Set(s) should cease use of the affected lots and contact Quest Medical, Inc. to return the product and request replacement. Additionally, consignees are being notified via written correspondence.
Customers with questions about the recall can contact Quest Medical by phone at (800) 627-0226 or by email at email@example.com.