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Class 2 Device Recall |
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Date Initiated by Firm |
April 18, 2019 |
Date Posted |
May 31, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1499-2019 |
Recall Event ID |
82703 |
510(K)Number |
K080592
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Product Classification |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
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Product |
Maquet Getinge-BEQ-TOP 8013 ECC QUADROX iD Pack RF32 Material: 701047962 |
Code Information |
Batch Numbers: 3000047630 3000050482 3000055980 3000060726 3000066813 3000068491 3000070813 3000074323 |
Recalling Firm/ Manufacturer |
Maquet Cardiovascular, LLC 45 Barbour Pond Dr Wayne NJ 07470-2094
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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
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FDA Determined Cause 2 |
Device Design |
Action |
Maquet 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 18886278383 (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: "BEQTOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051. |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = DWF and Original Applicant = MAQUET CARDIOPULMONARY AG
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