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Gambro Renal Products, Incorporated

Complete recall history across all FDA and CPSC categories — 18 total recalls

Gambro Renal Products, Incorporated appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (18)

FDA medical device enforcement actions by Gambro Renal Products, Incorporated

Date Product Reason Class
Jul 18, 2014 Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prisma M100 set. Product number 104182. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prisma M100 PRE pump infusion set. Product number 107791. Each set is package... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a pl... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MAR... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prismaflex M100. Product number 106697. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prisma HF1000 preset (new design). Product number 107639. Each set is package... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic ... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product ... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prismaflex M150. Product number 109990. Each set is packaged in a plastic pou... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Jul 18, 2014 Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plasti... Gambro initiated a field action on the Prisma and Prismaflex sets due to brea... Class II
Apr 16, 2014 Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Pr... The firm received several complaints for internal blood leaks involving vario... Class II
Apr 16, 2014 Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Ren... The firm received several complaints for internal blood leaks involving vario... Class II
Dec 9, 2013 Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Nu... Occluded heparin tubing events preventing anticoagulation dosing on the Gambr... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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