| Class 2 Device Recall Belzer UW & Waters IGL Cold Storage Solution | |
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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = KDN
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