Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
FDA Recall Z-1684-2021 · Posted None
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Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeFJK
Date Initiated2021-04-14
Date Terminated2024-05-10
Product Quantity17,487 units
Reason for Recall
There is a potential leak between the venous patient connector and patient's hemodialysis access.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - United States distribution and the countries of Canada, Korea, and Norway.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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