Recall Z-2197-2014— Gambro Renal Products, Incorporated

Name: FDA recall Z-2197-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-18

Class II · Terminated

Class II FDA medical device recall by Gambro Renal Products, Incorporated, initiated 2014-07-18, terminated 2015-02-05. It names one FDA 510(k) clearance: K032431. Product: Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box. Reason: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood..

Recalling firm: Gambro Renal Products, Incorporated
Classification: Class II
Status: Terminated
Initiated: 2014-07-18
Terminated: 2015-02-05
Firm location: Lakewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K032431 — PRISMA M60/M100 SETSGambro, Inc.·cleared 2003-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.