FDA-Device2018-04-18Class II
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.
Teleflex Medical Europe Ltd
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
6340 units
Manufactured in
Ida Business Park, Athlone, Ireland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1368-2018Don't want to check this manually?
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