Home / Recalls / Gambro Renal Products, Incorporated / Z-2195-2014

Z-2195-2014 Class II Terminated

Recalled by Gambro Renal Products, Incorporated — Lakewood, CO

Recall Details

Product Type
Devices
Report Date
August 20, 2014
Initiation Date
July 18, 2014
Termination Date
February 5, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
401,451

Product Description

Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box

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 Pattern

Worldwide Distribution.

Code Information

Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.

Other recalls by Gambro Renal Products, Incorporated

  • Z-2196-2014 Class II — Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a pl (July 18, 2014)
  • Z-2202-2014 Class II — Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, (July 18, 2014)
  • Z-2199-2014 Class II — Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged i (July 18, 2014)
  • Z-2201-2014 Class II — Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pou (July 18, 2014)
  • Z-2198-2014 Class II — Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, (July 18, 2014)
  • Z-2203-2014 Class II — Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, (July 18, 2014)
  • Z-2205-2014 Class II — Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pou (July 18, 2014)
  • Z-2194-2014 Class II — Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic po (July 18, 2014)
  • Z-2206-2014 Class II — PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS T (July 18, 2014)
  • Z-2197-2014 Class II — Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic p (July 18, 2014)