FDA recall Z-1368-2018

Teleflex Medical Europe Ltd · Class II · device

Product

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.

Reason for recall

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.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2018-03-15
Report date
2018-04-18
Termination date
2020-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athlone, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2018