Teleflex Medical Europe Ltd recalls Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into th…

Recall date

March 15, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1368-2018

FDA classification

Class II

Brand / firm

Teleflex Medical Europe Ltd

Sold / distributed

US Nationwide Distribution

Why it was recalled

These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled.