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Gambro Renal Products, Incorporated Recalls
18 recalls on record · April 23, 2014 to August 20, 2014 · Medical Devices
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The recall feeds record what looks like the same company under more than one name:
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Nu
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton b
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
August 20, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Hazard: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
May 28, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treat
Hazard: The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
May 28, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment
Hazard: The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
April 23, 2014Medical DevicesFDA
Gambro Renal Products, Incorporated recalls Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set
Hazard: Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.