| Class 2 Device Recall Affinity Pediatric Arterial Filter | |
Date Initiated by Firm | June 14, 2013 |
Date Posted | August 14, 2013 |
Recall Status1 |
Terminated 3 on March 07, 2014 |
Recall Number | Z-1966-2013 |
Recall Event ID |
65732 |
510(K)Number | K071253 |
Product Classification |
Filter, blood, cardiopulmonary bypass, arterial line - Product Code DTM
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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 MN 55112-4391
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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 | Employee error |
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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DTM
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