Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
FDA Recall Z-1860-2008 · Posted 2008-09-26
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Recalling FirmGambro Renal Products, Inc.
Recall StatusTerminated
Product CodeFJK
Date Initiated2008-05-02
Date Terminated2012-05-22
Reason for Recall
Dialysis tubing sets may have occlusions restricting blood flow.
Firm Action
Customers were sent an "Urgent Product Safety Notice" letter on 05/02/2008. They were instructed to visually inspect all blood sets prior to connection to the dialyzer to ensure there were no occlusions or partial occlusions. On 05/27/2008, an "Urgent Product Recall" letter was sent to all customers requesting the return of all remaining affected blood sets.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution --- including states of CA,GA, IL, KY, MO, NJ, NM, NY, NC, ND, PA, TN, and VA.
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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