Gambro Renal Products
Lakewood, CO, US
Gambro Renal Products appears in FDA device records in Lakewood, CO. FDA records list 37 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 30 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Gambro Renal Products carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Gambro Renal Products, Incorporatedenforcement report, recall
510(k) clearance history
FDA records hold 37 510(k) clearances for Gambro Renal Products between 2000 and 2014. The busiest year on record is 2005, with 6. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 6 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 2 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133807 | MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT | FLD | Substantially Equivalent | |
| K131516 | PRISMAFLEX SYSTEM 7.10 | KDI | Substantially Equivalent | |
| K130039 | REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER | KDI | Substantially Equivalent | |
| K113313 | MOLECULAR ADSORBENT RECIRCULATING(MARS) | FLD | Substantially Equivalent | |
| K120333 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY | KPO | Substantially Equivalent | |
| K110823 | PRISMAFLEX | KDI | Substantially Equivalent | |
| K103832 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM | KDI | Substantially Equivalent | |
| K100451 | GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 | MPB | Substantially Equivalent | |
| K100364 | GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 | FJK | Substantially Equivalent | |
| K093608 | GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H | FIP | Substantially Equivalent | |
| K080519 | PRISMAFLEX M150 SET | KDI | Substantially Equivalent | |
| K072908 | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY | KPO | Substantially Equivalent | |
| K070414 | GAMBRO CARTRIDGE BLOOD SETS | FJK | Substantially Equivalent | |
| K072232 | GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL | KDI | Substantially Equivalent | |
| K063183 | PRISMA M10 PRE SET | KDI | Substantially Equivalent | |
| K063290 | GAMBRO QUICKSET BLOODLINES | FJK | Substantially Equivalent | |
| K062090 | PRISMA SYSTEM R03.10A | KDI | Substantially Equivalent | |
| K060195 | GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE | KDI | Substantially Equivalent | |
| K051520 | GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H | KDI | Substantially Equivalent | |
| K052253 | MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | KPO | Substantially Equivalent | |
| K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR | FJI | Substantially Equivalent | |
| K033262 | MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) | FLD | Substantially Equivalent | |
| K042797 | WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS | FIP | Substantially Equivalent | |
| K042938 | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS | KDI | Substantially Equivalent | |
| K040301 | GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A | MPB | Unknown | |
| K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS | KDI | Substantially Equivalent | |
| K040255 | POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE | KDI | Substantially Equivalent | |
| K023615 | GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR | MSF | Substantially Equivalent | |
| K010805 | PRISMA SYSTEM | KDI | Substantially Equivalent | |
| K013448 | PRISMASATE | KPO | Substantially Equivalent | |
| K013724 | BICART | KPO | Substantially Equivalent | |
| K003957 | DIACLEAR ULTRAFILTER | FIP | Substantially Equivalent | |
| K011221 | PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET | KDI | Substantially Equivalent | |
| K010985 | GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L | KDI | Substantially Equivalent | |
| K011368 | DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS | KPO | Substantially Equivalent | |
| K010667 | GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R | KDI | Substantially Equivalent | |
| K001156 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET | KDI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FLDApparatus, Hemoperfusion, Sorbent
- MPBCatheter, Hemodialysis, Non-Implanted
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- MSFHemodialyzer, Re-Use, High Flux
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FIPSubsystem, Water Purification
Recall records
Showing 25 of 30| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0490-2015 | Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis. | Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier. | Class II | Terminated | |
| Z-0489-2015 | Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear and Polyflux Revaclear Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis. | Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier. | Class II | Terminated | |
| Z-2207-2014 | X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2206-2014 | PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2205-2014 | Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2204-2014 | Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2203-2014 | Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2202-2014 | Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2201-2014 | Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2200-2014 | Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2199-2014 | Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2198-2014 | Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2197-2014 | Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2196-2014 | Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2195-2014 | Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2194-2014 | Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-2193-2014 | Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box | Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood. | Class II | Terminated | |
| Z-1644-2014 | Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. | The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. | Class II | Terminated | |
| Z-1643-2014 | Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. | The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. | Class II | Terminated | |
| 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 transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems. | Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets. | Class II | Terminated | |
| Z-1901-2011 | Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. | Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure. | Terminated | ||
| Z-1861-2008 | Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems. | Dialysis tubing sets may have occlusions restricting blood flow. | Terminated | ||
| Z-1860-2008 | Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems. | Dialysis tubing sets may have occlusions restricting blood flow. | Terminated | ||
| Z-1367-2008 | Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401 | Kinked tubing on hemodialysis device may cause hemolysis. | Terminated | ||
| Z-0695-2007 | Gambro Prismaflex Continuous Renal Replacement System, Catalog Number 602314700, Gambro Lundia AB, Sweden. | Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines) | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Gambro Renal Products edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain