Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch Recalled by Gambro Renal Products, Incorporated Due to Gambro initiated a field action on the Prisma...

Date: July 18, 2014
Company: Gambro Renal Products, Incorporated
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Gambro Renal Products, Incorporated directly.

Affected Products

Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box

Quantity: 401,451

Why Was This Recalled?

Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

Where Was This Sold?

Worldwide Distribution.

About Gambro Renal Products, Incorporated

Gambro Renal Products, Incorporated has 18 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report