Food, drugs, devices › Gambro Renal Products, Incorporated
Device recall: Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated (Lakewood, CO) initiated this device recall on 18 Jul 2014; FDA lists 15 product records under event 68788, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 5 Feb 2015. Initiation: voluntary: firm initiated. Gambro Renal Products, Incorporated has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Gambro Renal Products, Incorporated, Lakewood, CO.
Reason for recall
"Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood."
Distribution
"Worldwide Distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2193-2014 | Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2194-2014 | Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| 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 | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2196-2014 | Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2197-2014 | Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2198-2014 | Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| 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 | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2200-2014 | Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2201-2014 | Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2202-2014 | Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2203-2014 | Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2204-2014 | Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2205-2014 | Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box | 401,451 | Class II | Terminated | 20 Aug 2014 |
| 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 | 401,451 | Class II | Terminated | 20 Aug 2014 |
| Z-2207-2014 | X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 | 401,451 | Class II | Terminated | 20 Aug 2014 |
Context
Other enforcement events for Gambro Renal Products, Incorporated
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Apr 2014 | Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of a | Device | Class II | 2 |
| 9 Dec 2013 | Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set | Device | Class II | 1 |
All 3 events for Gambro Renal Products, Incorporated
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Feb 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.