Recall Z-2193-2014— 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: Prismaflex TPE 2000 set, Product Number 1071441. 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
Product description
Prismaflex TPE 2000 set, Product Number 1071441. 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.