Recall Z-2107-2020 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
Quest Medical, Inc.
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)
| Date | Dec 17, 2019 |
| Status | Terminated |
| Reason | Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to deliver whole blood to the heart during open heart surgery, were swapped and incorrectly placed. This could lead to over delivery of potassium by the user requiring medical intervention. |
| Root cause | Under Investigation by firm |
| Action | Customers who received product/affected lot were to be contacted via letter, Urgent-Product Recall Notice, dated 12/6/2019 sent to customers via XXX. Customers were to review their inventory to see if they had products from the affected lot. If they did have these products they were to place the product in quarantine and contact Quest Medical, Inc. using a form included with the recall notification. It instructed customers to complete and return the enclosed response form to Tosan Onosode Regulatory Affairs Supervisor,Quest Medical, Inc.,One Allentown Parkway Allen, TX 75002-4211 USA, Ema |
| Quantity | 5 units |
| Distribution | US Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173716 | MPS2 Myocardial Protection System Console Quest Medical, Inc., Oct 1, 2018 |