Prismaflex HF 1000. Product number 107140. Each set is… recallZ-2204-2014 · Gambro Renal Products, Incorporated · initiated Jul 18, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gambro Renal Products, Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
FDA root cause category: Device Design
What the company is doing
Gambro sent an Urgent Field Safety Notice dated July 18, 2014 to all end-users. A Customer Reply Form was attached to the notice for customers to complete and return.
Recall details
- Recall number
- Z-2204-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 18, 2014
- Posted by the FDA
- Aug 13, 2014
- Recalling firm
- Gambro Renal Products, Incorporated
- Quantity
- 401,451
- Product code
- KDI
- FDA submissions
- K042938
- Distribution
- Worldwide Distribution.
Product description
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Code information (models, lots, serial numbers)
Prismaflex HF 1000. Product number 107140. Batch number 12A0504 to 14C3105. Expiry 01/2014 to 03/2016
Other devices under the same FDA submission
2 devices cleared under K042938 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PRISMAFLEX SET HF1000Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system2 recalls41 reports
- PRISMAFLEX SET HF1400Gambro Industries · Dialyzer, high permeability with or without sealed dialysate system2 recalls2 deaths32 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 68788).
- Z-2201-2014 · TerminatedPrismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2202-2014 · TerminatedPrismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2203-2014 · TerminatedPrismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Z-2205-2014 · TerminatedPrismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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