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U.S. Department of Health and Human Services

Class 2 Device Recall Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set

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  Class 2 Device Recall Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set see related information
Date Initiated by Firm December 30, 2020
Create Date February 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-1122-2021
Recall Event ID 87150
510(K)Number K070414  
Product Classification Set, tubing, blood, with and without anti-regurgitation valve - Product Code FJK
Product Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Code Information UDI 07332414112394, All lots within expiry
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		 complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm issued a Safety Alert on 12/30/2020 by mail. The letter explained the problem with photographs, and the hazard involved with using a device with a kinked line. Customers identifying set with kinked tubing may contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Distributor were asked to notify their customers by distributing the letter.
Quantity in Commerce 57825 devices
Distribution Worldwide distribution.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FJK and Original Applicant = GAMBRO RENAL PRODUCTS
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