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U.S. Department of Health and Human Services

Class 2 Device Recall Holder HKHZ 19 for use with Quadroxi and QuadroxiD Neonatal / Pediatric Oxygenators

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 Class 2 Device Recall Holder HKHZ 19 for use with Quadroxi and QuadroxiD Neonatal / Pediatric Oxygenatorssee related information
Date Initiated by FirmJune 18, 2020
Create DateAugust 12, 2020
Recall Status1 Terminated 3 on December 30, 2022
Recall NumberZ-2780-2020
Recall Event ID 86020
Product Classification Accessory equipment, cardiopulmonary bypass - Product Code KRI
ProductHolder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QUADROX iD Neonatal / Pediatric Oxygenator and can also be used in combination with the holder's arm (016061) to use in cardiopulmonary bypass procedures (CPB) in a pediatric patient population.
Code Information Model Number: 701047495 Part Number: HKHZ 19 UDI Code: 04037691533339 Lot# 70128207
FEI Number 3008355164
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information ContactRachana Patel
973-709-7412
Manufacturer Reason
for Recall		Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
FDA Determined
Cause 2		Under Investigation by firm
ActionGetinge sent a customer letter dated July 2020 instructing customers to remove the affected products from areas of use and return the product(s) to Getinge following the provided instructions.
Quantity in Commerce50 units
DistributionWorldwide distribution - US Nationwide distribution including in the states of OH, PA, SC, CT and the countries of Germany, Spain, France, United Kingdom, Italy, United Arab Emirates, Mexico, Canada, Croatia, Georgia, Poland, Slovakia, Thailand, and Vietnam.
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.
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