Class II — Potential Health Hazard

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

RS 5F DL BIOFLO PASV Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) Due to A component of the kits might contain unsafe...

Date: May 10, 2018
Company: Angiodynamics Inc. (Navilyst Medical Inc.)
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 Angiodynamics Inc. (Navilyst Medical Inc.) directly.

Affected Products

RS 5F DL BIOFLO PASV, Catalog Number 60M161567

Quantity: 2 boxes

Why Was This Recalled?

A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

Where Was This Sold?

This product was distributed to 34 states: AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, WA, WV, WI, DC

Affected (34 states)Not affected

About Angiodynamics Inc. (Navilyst Medical Inc.)

Angiodynamics Inc. (Navilyst Medical Inc.) has 78 total recalls tracked by RecallDetector.

Related Recalls

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