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U.S. Department of Health and Human Services

Class 2 Device Recall Affinity Pediatric Arterial Filter

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 Class 2 Recall
Affinity Pediatric Arterial Filter
see related information
Date Posted August 14, 2013
Recall Status1 Terminated on March 07, 2014
Recall Number Z-1966-2013
Recall Event ID 65732
Premarket Notification
510(K) Number
K071253 
Product Classification Filter, Blood, Cardiopulmonary Bypass, Arterial Line - Product Code DTM
Product Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli greater than the specified micron size from the circuit for periods up to 6 hours during cardiopulmonary bypass surgery. These devices are available both in an uncoated and a Carmeda coated option. The Carmeda coating is a BioActive surface that is non-leaching and provides a thromboresistant blood contact surface.
Code Information Lot Numbers: 12635577 and 12637041 Updated infrormation on 9/6/13 to include Lot # 12645672
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul, Minnesota 55112-4391
For Additional Information Contact Technical Services
877-526-7890
Manufacturer Reason
for Recall
Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Customer communication was initiated verbally on June 14, 2013, to the 4 affected customers to quarantine any un-used units. An Urgent Medical Device Recall letter, dated June 26, 2013. was mailed to customers on June 28, 2013. The Urgent Medical Device letter referenced that the letter is in follow-up to the previous phone call. It identified the affected product, stated the issue with the 2 affected lot numbers and health risks, and asked that the affected devices be quarantined for return to Medtronic. If you have any questions please contact your Medtronic Sales representative or Lifeline Technical Services at 1-877-526-7890. 1-763-526-7890. Update: Customer communication to the newly identified customer was initiated verbally on August 20,2013, with the customer letter delivery beginning AUG 27, 2013. A Medtronic representative is available to facilitate the return of affected product.
Quantity in Commerce 153 devices.
Distribution Worldwide Distribution - US Distribution only to MS and IL, and the countries of Argentina, South Africa and Singapore.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DTM and Original Applicant = MEDTRONIC VASCULAR
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