Gambro Renal Products, Incorporated: FDA recalls
FDA enforcement reports name Gambro Renal Products, Incorporated as the recalling firm in 3 events. The events have 18 product records. The recalls started from 2013 to 2014. All the events are device recalls.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
3 events, newest first.
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 18 Jul 2014 | Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box | Device | Class II | 15 | Terminated |
| 16 Apr 2014 | Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. | Device | Class II | 2 | Terminated |
| 9 Dec 2013 | 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… | Device | Class II | 1 | Terminated |
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
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Type and class
| Type | Events |
|---|---|
| Device | 3 |
| Class | Events |
|---|---|
| Class II | 3 |
- Share of the events of the firm in Class I
- 0%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 0
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. Gambro Renal Products, Incorporated: FDA recalls. https://recallregister.com/firm/gambro-renal-products-incorporated/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- State of the firm address
- CO
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of Gambro Renal Products, Incorporated have?
- Class II: 3 events. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of Gambro Renal Products, Incorporated?
- FDA event 68788, which the firm started on 18 Jul 2014. The first product in the record is:
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
- How many FDA recalls of Gambro Renal Products, Incorporated have the status Ongoing?
- No event has the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.