The Recall Desk

Manufacturer

Gambro Renal Products, Incorporated

18 recalls in our database name Gambro Renal Products, Incorporated as the manufacturing or recalling firm.

What the numbers show

Total
18
Critical
0
Severe
6
Most recent
2014-08-20

Of the 18 recalls from Gambro Renal Products, Incorporated we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–18 of 18

  • SevereFDA (Devices)·Z-2202-2014·2014-08-20

    Gambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2203-2014·2014-08-20

    Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.

    Product
    Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2206-2014·2014-08-20

    Gambro Recalls PrisMARS Kits Due to Connector Breakage and Leakage

    Gambro Renal Products is recalling PrisMARS Kits because connector breakages can cause liquid or blood to leak.

    Product
    PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2204-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1000 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2199-2014·2014-08-20

    Gambro Recalls Prisma M100 PRE Pump Infusion Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.

    Product
    Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2200-2014·2014-08-20

    Gambro Recalls Prisma HF1000 Presets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma HF1000 presets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2196-2014·2014-08-20

    Gambro Recalls Prisma M60 Postdilution Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M60 POSTDILUTION sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2195-2014·2014-08-20

    Gambro Recalls Prisma M 60 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 60 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2197-2014·2014-08-20

    Gambro Recalls Prisma M 100 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 100 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2205-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1400 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1400 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2194-2014·2014-08-20

    Gambro Recalls Prisma TPE 2000 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma TPE 2000 sets because connector breakages can cause liquid or blood leakage.

    Product
    Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2201-2014·2014-08-20

    Gambro Recalls Prismaflex M60 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M60 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2207-2014·2014-08-20

    Gambro Recalls X-MARS Sets Due to Connector Breakage and Leakage

    Gambro Renal Products is recalling X-MARS Sets because connector breakages can cause leakage of liquid or blood.

    Product
    X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2198-2014·2014-08-20

    Gambro Recalls Prisma M100 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M100 sets because connector breakages can cause liquid or blood to leak.

    Product
    Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2193-2014·2014-08-20

    Gambro Recalls Prismaflex TPE 2000 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex TPE 2000 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1644-2014·2014-05-28

    Gambro Polyflux Revaclear Max Dialyzers Recalled for Internal Blood Leaks

    Gambro Renal Products is recalling Polyflux Revaclear Max dialyzers due to reports of internal blood leaks. The recall covers 2,461,824 units distributed worldwide.

    Product
    Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1643-2014·2014-05-28

    Gambro Polyflux Revaclear Dialyzers Recalled for Internal Blood Leaks

    Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.

    Product
    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1455-2014·2014-04-23

    Gambro Cartridge Blood Sets Recalled Due to Occluded Heparin Tubing

    Gambro Renal Products is recalling specific Gambro Cartridge Blood Sets because occluded heparin tubing may prevent anticoagulation dosing during hemodialysis.

    Product
    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 extrac
    Category
    Medical Device
    Distribution
    Distributed nationwide