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U.S. Department of Health and Human Services

Class 2 Device Recall Gambro Cartridge Blood Set

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  Class 2 Device Recall Gambro Cartridge Blood Set see related information
Date Initiated by Firm April 14, 2021
Create Date May 26, 2021
Recall Status1 Terminated 3 on May 10, 2024
Recall Number Z-1684-2021
Recall Event ID 87739
510(K)Number K070414  
Product Classification Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
Product Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Code Information Product Code: 101025; Lot 1000276191, UDI: 37332414007837
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 There is a potential leak between the venous patient connector and patient's hemodialysis access.
FDA Determined
Cause 2		 Under Investigation by firm
Action An Urgent Medical Device Recall communication will be sent to affected customers via USPS, first class mail. Baxter is asking customers to: 1) Locate and remove all affected product from your facility. 2) Contact Baxter Healthcare Center for Service to arrange for return and credit. 3) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by email.
Quantity in Commerce 17,487 units
Distribution Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
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 = FJK and Original Applicant = GAMBRO RENAL PRODUCTS
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