MPS Top Cover Replacement Kit Recalled Due to Swapped Labels
Quest Medical is recalling MPS Top Cover Replacement Kits because additive and arrest agent labels were swapped, posing a risk of over-delivering potassium during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (over-delivery of potassium requiring medical intervention) during a critical surgical procedure.
Plain-English summary
Quest Medical, Inc. is recalling 5 units of the MPS Top Cover Replacement Kit (Ref 801168, Lot 059135). The device is a component of the MPS Console, used as a replacement for worn or damaged top covers on cardiopulmonary bypass heat exchangers. These exchangers are used to deliver whole blood to the heart during open heart surgery.
The recall was initiated because the additive and arrest agent labels on the kits were swapped and incorrectly placed. This labeling error could lead to the over-delivery of potassium by the user, which would require medical intervention.
The affected units were distributed nationwide in the United States, specifically in New York, Pennsylvania, Tennessee, and West Virginia. No units were distributed outside the U.S. Healthcare facilities and users should stop using the affected kits and contact Quest Medical for instructions on return or replacement.
The recalled product
- Product
- 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)
- Manufacturer
- Quest Medical, Inc.
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 059135
Distribution
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