Recall Z-1294-2021— TELEFLEX MEDICAL INC

Name: FDA recall Z-1294-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-18

Class II · Ongoing

Class II FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2021-02-18. FDA's recall record names no specific 510(k) clearance for this event. Product: RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.. Reason: Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge..

Recalling firm: TELEFLEX MEDICAL INC
Classification: Class II
Status: Ongoing
Initiated: 2021-02-18
Firm location: Morrisville, NC, United States

Product description

RUSCH¿ POLARIS" Laryngoscope - Product Usage: intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

Reason for recall

Teleflex is voluntarily recalling the products referenced above due to customers reporting that the laryngoscope handles develop cracks and/or break at the hinge.

Data sourced from openFDA. This site is unofficial and independent of the FDA.