Reported Apr 18, 2018 · Terminated

Rectal Catheters; Product Code Equivalent Code 580114 580114 Product Usage: Rectal Balloon Catheter is inserted into…

Teleflex Medical Europe Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teleflex Medical Europe Ltd · Ida Business Park · Athlone · N/A

Is this the product you have?

  • Rectal Catheters; Product Code Equivalent
  • Code 580114 580114 Product UsageRectal Balloon Catheter is inserted into the rectum to measure the abdominal pressure as bladder filled
Lot codes and dates
  • Batch Numbers
    • 13DE17
    • 13EE22
    • 13FE24
    • 13FE26
    • 13GE28
    • 13GE29
    • 13GE31
    • 13KE47
    • 13LE49
    • 14AE03
    • 14AE04
    • 14FE25
    • 14GE27
    • 14HE32
    • 14HE33
    • 14HE35
    • 14IE37
    • 14IE38
    • 14LE49
    • 15AE05
    • 15BE08
    • 15CE13
    • 15DE15
    • 15DE16
    • 15DE17
    • 15DE18
    • 15FE23
    • 15FE25
    • 15FE26
    • 15GE27
    • 15GE28
    • 15GE29
    • 15GE30
    • 15HE32
Amount recalled
6340 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 5, 2020 · Data as of Sep 19, 5:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.