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U.S. Department of Health and Human Services

Class 3 Device Recall Belzer UW Cold Storage Solution

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  Class 3 Device Recall Belzer UW Cold Storage Solution see related information
Date Initiated by Firm September 24, 2010
Date Posted November 22, 2010
Recall Status1 Terminated 3 on April 02, 2012
Recall Number Z-0427-2011
Recall Event ID 56913
510(K)Number K073693  
Product Classification System, perfusion, kidney - Product Code KDN
Product Belzer UW Cold Storage Solution, 1000 mL. Sterile and non-pyrogenic. Formulated for flushing and cold storage of kidney, liver and pancreas organs. Manufactured by: Preservation Solutions, Inc., Elkhorn, WI 53121. Manufactured for: BTL Solutions LLC, a subsidiary of Bridge to Life, Ltd., 1225 Laurel Street, Columbia, SC 29201.
Code Information Batch # Bt017170, Lot# BC071710
Recalling Firm/
Manufacturer		 Preservation Solutions Inc
980 Proctor Dr.
P.O. Box 937
Elkhorn WI 53121-0937
For Additional Information Contact Bobbi Rader
262-723-6715
Manufacturer Reason
for Recall		 Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter.
FDA Determined
Cause 2		 Labeling mix-ups
Action Bridge to Life, Ltd, issued a Notification of Product Recall letter dated October 18, 2010 to all direct accounts identifying the affected product and labeling issue. Customers were informed that all product from the affected lot has been replaced by the firm. Customers with questions about this recall can contact Bridge to Life at 803 673-4548..
Quantity in Commerce 55 units
Distribution Nationwide Distribution - in US to the states of CA, MO, and PA.
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 = KDN and Original Applicant = PRESERVATION SOLUTIONS, INC.
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