Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1455-2014 — 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 trans

U.S. FDA — Device Enforcement · United States · 2013-12-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1455-2014
Date of alert: 2013-12-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Gambro Renal Products, Incorporated
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 1000039228

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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