Recall archive
3 recalls · page 1 of 1
Reported Aug 20, 2014
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gambro Renal Products, Incorporated
Matched: Brand · Reason for recall — Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
14 more products in this recall
FDA (openFDA device enforcement)
Reported May 28, 2014
Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gambro Renal Products, Incorporated
Matched: Brand · Product · Product details — The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2014
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Gambro Renal Products, Incorporated
Matched: Brand · Product · Product details · Reason for recall — Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
FDA (openFDA device enforcement)
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