| Class 3 Device Recall ONE SOURCE PACK, Model TK2S24 | |
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
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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
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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 |
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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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