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U.S. Department of Health and Human Services

Class 2 Device Recall Belzer UW & Waters IGL Cold Storage Solution

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  Class 2 Device Recall Belzer UW & Waters IGL Cold Storage Solution see related information
Date Initiated by Firm February 26, 2018
Create Date April 16, 2018
Recall Status1 Terminated 3 on September 09, 2022
Recall Number Z-1387-2018
Recall Event ID 79378
510(K)Number K073693  
Product Classification System, perfusion, kidney - Product Code KDN
Product Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002.

Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient.
Code Information UDI 00810805000163, and UDI 00810805000071. 
Recalling Firm/
Manufacturer		 Preservation Solutions, Inc.
1099 Proctor Dr
Elkhorn WI 53121-2027
For Additional Information Contact
262-723-6715
Manufacturer Reason
for Recall		 Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent: Product Recall Notification letters, dated February 26, 2018, were sent to consignees. The instructions include, halting distribution of any 2 Liter bags in inventory; and, arranging for the return of affected units. Preservation Solutions, Inc. provided a notification letter for their consignees to provide to their customers. The letter instructed customers to return any 2 Liter bags to their supplier, and to complete and return the acknowledgement form.
Quantity in Commerce 31,104 units
Distribution Worldwide Distribution -- 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 = KDN and Original Applicant = PRESERVATION SOLUTIONS, INC.
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