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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet/Getinge

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  Class 2 Device Recall Maquet/Getinge see related information
Date Initiated by Firm November 13, 2019
Create Date December 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-0677-2020
Recall Event ID 84352
510(K)Number K100278  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile
REF: BEQ-HMOD 30000
Code Information Lot codes: 70114704, 70120471, 70123847, 70123854, 70124528, 70124693, 70127336, 70130216, 70123853, 70129395, 7011472 05, 70121444, 70123849, 70124474, 70124529, 70124694, 70127498, 70131871, 70124527, 70113694, 70120282, 70121445, 70123850, 70124525, 70124689, 70124695, 70127499, 70120470, 70124692, 70120283, 70121668, 70123852, 70124526, 70124691, 70124696, 70128623, 70122004, 70127335  UDI Code: 04037691670164
Recalling Firm/
Manufacturer		 GETINGE US SALES LLC
45 BARBOUR POND DR
WAYNE NJ 07470
Manufacturer Reason
for Recall		 Sterile barrier system may be compromised
FDA Determined
Cause 2		 Package design/selection
Action Getinge issued Urgent Medical Device Removal Letter on 11/13/19 via Fedex 2 Day delivery with Signature Proof of Delivery (SPOD) required. Letter states" Identification of Issue, Health Risk and action to take: examine your inventory immediately to determine if you have any of the lot/batch numbers listed in this recall notice. If so, please remove the affected products from areas of use and follow the instructions to return of the product to Getinge. Unused and unexpired affected product that is returned to Getinge is eligible for full credit. Affected product should be returned to Getinge. Call Maquet/Getinge Customer Support at +1(888) 627- 8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a return material authorization (RMA) and shipping instructions to return any affected product. Complete the response form and return fax or email the completed Customer Response Form to 1-800-574-5051 OR QuadroxiDPediatricFA.US@getinge.com
Quantity in Commerce 3633 US
Distribution Nationwide Canada
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DTZ and Original Applicant = MAQUET CARDIOPULMONARY AG
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