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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 18, 2019
Date PostedMay 31, 2019
Recall Status1 Terminated 3 on July 28, 2025
Recall NumberZ-1646-2019
Recall Event ID 82703
510(K)NumberK080592 
Product Classification Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
ProductMaquet Getinge: (1) Material: 701053941R01 BEQ-TOP 9005 3/8 Custom Pk w/RF32 & HMOD (2) Material: 701053941R02- BEQ-TOP 9005 3/8 Custom Pk w RF32 & HMOD Material:
Code Information Batch Numbers:  (1) 3000051652 3000054808 3000058733 3000062473 3000071201 3000073170 3000075123 (2) 3000076148 3000081600 
FEI Number 2242352
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer Reason
for Recall		Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
FDA Determined
Cause 2		Device Design
ActionMaquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 1 888 627 8383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time. On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQ TOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051.
DistributionNationwide
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 = DWF
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