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U.S. Department of Health and Human Services

Class 3 Device Recall ONE SOURCE PACK, Model TK2S24

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  Class 3 Device Recall ONE SOURCE PACK, Model TK2S24 see related information
Date Initiated by Firm December 14, 2009
Date Posted February 26, 2010
Recall Status1 Terminated 3 on April 20, 2011
Recall Number Z-0869-2010
Recall Event ID 54237
Product Classification Cardiopulmonary bypass accessory equipment. - Product Code KRI
Product ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604.
Code Information Lot #: 1093645, 1102929, 1139554
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy
Minneapolis MN 55432-5603
For Additional Information Contact
763-505-2562
Manufacturer Reason
for Recall		 Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The UBD on the outer label of the kit/pack does not accurately reflect the UBD of the components within the kit/Pack. For affected product, the outer label lists a date which may be later than the USB of the components inclu
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" dated December 14, 2009. The letter was addressed to "Valued Customer." The letter described the product and the problem and requested them to quarantine the product and to complete and sign the attached certificate, "Medtronic Recall Certificate (FCA 1002)." For additional information, contact the firm at 763-514-9605.
Quantity in Commerce 12
Distribution CA, CO, JAPAN, CHINA.
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.
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