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U.S. Department of Health and Human Services

Class 2 Device Recall Perfadex with THAM

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  Class 2 Device Recall Perfadex with THAM see related information
Date Initiated by Firm May 12, 2011
Date Posted July 12, 2011
Recall Status1 Terminated 3 on July 15, 2011
Recall Number Z-2795-2011
Recall Event ID 58824
510(K)Number K081997  
Product Classification Isolated organ transport system transport and preservation buffer (Trometamol) - Product Code MSB
Product XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs.

Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.
Code Information Addex THAM 50, lot number 2570350.  Relabeled and distributed as THAM, REF 99019, lots 502518, 502590, 502663, 502664, 502688, 502709, 502735, 502774, 502809, 502822, 502834.  Perfadex with THAM kit, 8 x 1000mL REF 19017,  502522 (502518) 502591 (502590) 502662 (502664) 502689 (502688) 502734 (502735) 502807 (502809) 502835 (502834). (Number in parenthesis is THAM LOT number used in kit)  Perfadex with THAM kit 2 x 2800mL REF 19018:  502521 (502518) 502663 (502664) 502708 (502709) 502743 (502774) 502808 (502809) 502823 (502822) 502826 (502822). (Number in parenthesis is THAM LOT number used in kit)
Recalling Firm/
Manufacturer		 Vitrolife, Inc.
3601South Inca Street
Englewood CO 80110
For Additional Information Contact
303-762-1933
Manufacturer Reason
for Recall		 Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.
FDA Determined
Cause 2		 Process control
Action XVIVO Perfusion, part of the Vitrolife Group, sent out a "Partial recall of Perfadex with THAM" letter on May 13, 2011 to all affected customers. Customers were instructed to to quarantine all Perfadex with THAM. Replacement THAM was to be shipped by Vitrilife within a few days and the exchanged THAM was to immediately sent to Vitrolife, Englewood, CO. For additional Information please call (303) 762-1933
Quantity in Commerce 1457 bottles
Distribution Worldwide distribution including USA and Europe.
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 = MSB and Original Applicant = VITROLIFE SWEDEN AB
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