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U.S. Department of Health and Human Services

Class 2 Device Recall Affinity Arterial Filter, Uncoated, 38um

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  Class 2 Device Recall Affinity Arterial Filter, Uncoated, 38um see related information
Date Initiated by Firm November 14, 2019
Create Date December 17, 2019
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-0693-2020
Recall Event ID 84410
510(K)Number K952532  
Product Classification Filter, blood, cardiopulmonary bypass, arterial line - Product Code DTM
Product Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Code Information UDI 20643169858835, Lot Numbers: 13316512
Recalling Firm/
Manufacturer		 Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact Medtronic Technical Services
877-526-7890
Manufacturer Reason
for Recall		 Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
FDA Determined
Cause 2		 Process control
Action Beginning 14-Nov-2019, Medtronic initiated an immediate Urgent Medical Device Recall via verbal communication to one (1) customer that was shipped the affected product according to Medtronic records. The customer was asked to identify and quarantine any unused affected product. The immediate communication was followed by a written urgent medical device recall notification beginning on 26-Nov-2019 to communicate the issue to the one (1) customer that received affected product. The consignee was asked to confirm receipt of urgent medical device recall notification via a Customer Confirmation Certificate. Medtronic is seeking the return of the affected product.
Quantity in Commerce 24 units
Distribution CA
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 = DTM and Original Applicant = AVECOR CARDIOVASCULAR, INC.
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