Reported Aug 20, 2014 · Terminated
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gambro Renal Products, Incorporated · 14143 Denver West Pkwy · Lakewood, CO · 80401-3266
Is this the product you have?
- Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
- Lot codes and dates
- Prismaflex M150. Product number 109990. Batch number 12A0304G to 14C2706. Expiry 01/2014 to 03/2016
- Amount recalled
- 401,451
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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