Recall Z-2206-2014— Gambro Renal Products, Incorporated
Class II · Terminated
Class II FDA medical device recall by Gambro Renal Products, Incorporated, initiated 2014-07-18, terminated 2015-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch. 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
Product description
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
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.