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U.S. Department of Health and Human Services

Class 2 Device Recall Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface.

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  Class 2 Device Recall Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface. see related information
Date Initiated by Firm October 31, 2014
Date Posted December 16, 2014
Recall Status1 Terminated 3 on August 11, 2015
Recall Number Z-0531-2015
Recall Event ID 69746
510(K)Number K123314  K132972  
Product Classification Oxygenator, cardiopulmonary bypass - Product Code DTZ
Product The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.
Code Information Lot number 12981001 with the following Serial Numbers:  8110138055 8110141155 8110141281 8110141459 8110138056 8110141162 8110141304 8110141469 8110138061 8110141167 8110141305 8110141471 8110138096 8110141168 8110141315 8110141497 8110139306 8110141182 8110141320 8110141518 8110139330 8110141184 8110141331 8110141527 8110139856 8110141188 8110141335 8110141533 8110140819 8110141193 8110141342 8110141587 8110140824 8110141215 8110141368 8110141604 8110140985 8110141219 8110141380 8110141605 8110141045 8110141222 8110141391 8110141613 8110141082 8110141230 8110141403 8110141616 8110141083 8110141238 8110141415 8110141621 8110141114 8110141240 8110141416 8110141705 8110141119 8110141244 8110141418 8110141731 8110141127 8110141247 8110141421 8110141739 8110141128 8110141253 8110141423 8110141750 8110141138 8110141258 8110141431 8110141782 8110141142 8110141260 8110141445 8110141788 8110141153 8110141279 8110141452 8110141798  UPDATED:  Lot # 13011880, 13 (serial # 8110141520), 13023057 (Serial # 8110141435 and 8110141539).
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Lifeline Technical Services
877-529-7890
Manufacturer Reason
for Recall		 Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additional lots affected.
FDA Determined
Cause 2		 Process control
Action On October 31, 2014, Medtronic field representatives began verbally notifying consignees of the issue, requesting the quarantine and return of un-used, affected product. As a follow-up to these verbal notifications, on November 12, 2014, a Medtronic "Urgent Medical Device Recall" letter dated November 2014 was hand delivered by Medtronic field personnel, and was also sent to account risk managers via UPS. The letter described the problem, the product affected by the recall and actions to be taken. Consignees were asked to immediately quarantine, remove and return all affected product to Medtronic; contact customer service at 1-800-854-3570 to initiate a return, and complete and return the attached Customer Confirmation Certificate via email to: RS.CFQFCA@Medtronic.com or fax to: Medtronic at 651-367-0612 to the attention of Customer Focused Quality. For questions they can contact their Medtronic sales representative or Lifeline Technical Services at 1-877-526-7890. UPDATE: Consignees were hand delivered an updated letter dated March 2015 concerning the additional affected product.
Quantity in Commerce 66, UPDATE: 168 additional devices.
Distribution US Distribution to states of: CA and FL. UPDATED: OUS: Czech Republic and Switzerland.
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 = MEDTRONIC INC.
510(K)s with Product Code = DTZ and Original Applicant = MEDTRONIC, INC.
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