Class II — Potential Health Hazard

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

Xcela PICC with PASV Valve Technology/Kit 5 F-55cm Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) Due to Mislabeling

Date: October 17, 2017
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

Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995

Quantity: 4 boxes (5/each)= 20 eaches

Why Was This Recalled?

Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).

Where Was This Sold?

Canada

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