Recall Z-1127-2022— TELEFLEX MEDICAL INC

Name: FDA recall Z-1127-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-11

Class II · Ongoing

Class II FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2022-04-11. FDA's recall record names no specific 510(k) clearance for this event. Product: (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.. Reason: Reports received of torn corrugated breathing tubes..

Recalling firm: TELEFLEX MEDICAL INC
Classification: Class II
Status: Ongoing
Initiated: 2022-04-11
Firm location: Morrisville, NC, United States

Product description

(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.

Reason for recall

Reports received of torn corrugated breathing tubes.

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