Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Quadrox iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Quadrox iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating see related information
Date Initiated by Firm September 22, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on September 18, 2014
Recall Number Z-0689-2012
Recall Event ID 60673
510(K)Number K100278  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product MAQUET QUADROX iD PEDIATRIC -OXYGENATOR:
BEQ-HMOD 3000; Made In Germany

The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.The utilization period for this device is restricted to six hours.
Code Information 510(k) numbers: 1<100278 (Bioline coated) Device Listing No. 0098004 BEQ-HMOD 30000 70064002-28 units 70064004-140 units 
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
For Additional Information Contact Ms. Karen LeFevere
973-709-7652
Manufacturer Reason
for Recall		 There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator.
FDA Determined
Cause 2		 Device Design
Action The firm, Maquet Getinge Group, sent an "PRODUCT RECALL URGENT-MEDICAL DEVICE REMOVAL ACTION" letter dated September 22, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed tocheck their remaining inventory; remove product immediately to prevent use; remove the boxes or individually pouched oxygenators in a secure area of their facility and notify their MAQUET representative (a representative will physically remove the recalled product and replenish the removed units); and complete and return the enclosed Product Removal Disposition Form via fax to: (973)-807-9210 or email: whitney.torning@maquet.com. Should you have any questions or concerns, please do not hesitate to contact MAQUET Customer Service at 800-777-4222.
Quantity in Commerce 168 units
Distribution Nationwide distribution: AL, CA, DE, DC, FL, GA, HI, IL, IN, LA, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, and TX.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DTZ and Original Applicant = MAQUET CARDIOPULMONARY AG
-
-