Class II — Potential Health Hazard

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

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Recalled by Arrow International Inc Due to Product contains dry natural rubber latex. Label states...

Date: May 23, 2018
Company: Arrow International 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 Arrow International Inc directly.

Affected Products

Percutaneous Sheath Introducer Kit for use with 7 - 7.5 Fr. Catheters (8 Fr. 10 cm sheath length .035 inch dia. spring-wire guide), REF ES-09807. The percutaneous sheath introducer permits venous access and catheter introduction to the central circulation.

Quantity: 60 units

Why Was This Recalled?

Product contains dry natural rubber latex. Label states Latex Free.

Where Was This Sold?

Puerto Rico

About Arrow International Inc

Arrow International Inc has 431 total recalls tracked by RecallDetector.

Related Recalls

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