Home / Recalls / Gambro Renal Products, Incorporated / Z-2197-2014

Z-2197-2014 Class II Terminated

Recalled by Gambro Renal Products, Incorporated — Lakewood, CO

FDA device recall Z-2197-2014 was initiated by Gambro Renal Products, Incorporated on July 18, 2014 and is designated Class II. 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. The recall status is terminated (terminated February 5, 2015). Affected quantity: 401,451.

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 100 PRE set. Product number 103657. 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 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016

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Z-2193-2014 Class II — Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plast (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-2196-2014 Class II — Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a pl (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-2195-2014 Class II — Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in (July 18, 2014)
Z-2207-2014 Class II — X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Num (July 18, 2014)
Z-2204-2014 Class II — Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pou (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)