Quest Medical recalls 1 unit of MPS Top Cover Replacement Kit (UDI: 01)2 0634624 81168 7) due to potential potassium overdelivery during open heart surgery. Affected units may require medical intervention.
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.
Quest Medical is recalling one MPS Top Cover Replacement Kit for open heart surgery use. The kit may have incorrect labels causing potassium overdelivery, which could require medical intervention.
The kit's additive and arrest agent labels were swapped during manufacturing. This could cause the user to deliver too much potassium during heart surgery, requiring medical intervention.
Surgical teams using the MPS Top Cover Replacement Kit for cardiopulmonary bypass heat exchangers during open heart surgery are most at risk. Only one unit is affected.
Check for the UDI code (01)2 0634624 81168 7 on the kit. The affected unit was sold with lot number 059135.
Verify the additive and arrest agent labels match the correct sequence to avoid potassium overdelivery.
Only 1 unit is affected with the UDI code (01)2 0634624 81168 7 and lot number 059135.
Incorrect labels could cause potassium overdelivery during heart surgery, requiring medical intervention.
No immediate stop is required, but check labels to ensure correct usage.
We’ve drafted a message you can send Quest Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2107-2020 — Quest Medical Quest Medical Hello, I own a Quest Medical that is covered by recall Z-2107-2020 from Quest Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
