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U.S. Department of Health and Human Services

Class 2 Device Recall MPS2 Myocardial Protection System Console

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 Class 2 Device Recall MPS2 Myocardial Protection System Consolesee related information
Date Initiated by FirmDecember 17, 2019
Create DateMay 22, 2020
Recall Status1 Terminated 3 on April 17, 2024
Recall NumberZ-2107-2020
Recall Event ID 85389
510(K)NumberK173716 
Product Classification Heat-exchanger, cardiopulmonary bypass - Product Code DTR
ProductRef 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)
Code Information Lot Number: 059135
FEI Number 3001665800
Recalling Firm/
Manufacturer		 Quest Medical, Inc.
1 Allentown Pkwy
Allen TX 75002-4206
For Additional Information ContactTosan Onosode
800-627-0226 Ext. 338
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionCustomers 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, Email: tonosode@questmedical.com Fax: +1 469-795-2338, Phone: +1 800-627-0226 ext. 338 so that they can arrange to correct the labeling defect on these units. It further stated that If customers had any questions or concerns regarding this action, they should contact Tosan Onosode, Regulatory Affairs Supervisor, Recall Coordinator at 1-800-627-0226, ext. 338.
Quantity in Commerce5 units
DistributionUS Nationwide distribution including in the states of NY, PA, TN, WV. OUS: None
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DTR
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