CLASS II Device recall · Reported 20 Aug 2014 · FDA Enforcement Report
Prisma M 60 PRE set (new design) recalled by Gambro Renal Products
Gambro Renal Products is recalling Prisma M 60 PRE set (new design). The recall was initiated on 18 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2195-2014
- FDA event ID
- 68788
- Recalling firm
- Gambro Renal Products, Lakewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2014
- FDA classified
- 13 Aug 2014
- Reported
- 20 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 18 Jul 2014 | Recall initiated by company | |
| 13 Aug 2014 | Classified by FDA | +26 days |
| 20 Aug 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
Where it was distributed
Worldwide Distribution.
Questions about this recall
Why was it recalled?
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Which lots are affected?
Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 68788This product is part of a recall event; the main page for the event is Prisma M 100 PRE set recalled by Gambro Renal Products.
More recalls from Gambro Renal Products
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Polyflux Revaclear Dialyzer recalled by Gambro Renal Products | Gambro Renal Products | Sterility | Nationwide |
| Device | CLASS II | Polyflux Revaclear Max Dialyzer recalled by Gambro Renal Products | Gambro Renal Products | Sterility | Nationwide |
| Device | CLASS II | Prismaflex HF recalled by Gambro Renal Products | Gambro Renal Products | Packaging Defects | CO |
| Device | CLASS II | Prisma M100 set recalled by Gambro Renal Products | Gambro Renal Products | Packaging Defects | CO |
| Device | CLASS II | Prismaflex M60 set recalled by Gambro Renal Products | Gambro Renal Products | Packaging Defects | CO |
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| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |