FDAFDA · Food and drugs·Recall number 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
Published August 20, 2014 · Recall initiated: July 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Gambro Renal Products, Incorporated
- Distributor
- Worldwide Distribution.
- Lot
- Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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