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Terminated

Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

FDA Recall Z-1455-2014 · Posted 2014-04-11

Recalling FirmGambro Renal Products, Incorporated
Recall StatusTerminated
Product CodeFJK
Date Initiated2013-12-09
Date Terminated2015-12-22
Product Quantity306,525 sets (20435 boxes of 15 sets)

Reason for Recall

Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

Firm Action

On 12/9/13 and 3/12/14, a field safety notice sent via UPS overnight delivery informing customers of issue and if any customer wants to return product, a hold at distribution centers and manufacturer quarantine areas. Upon reconciliation of returned product a destruction disposition with certification.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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