Reported May 27, 2020 · Terminated

AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the…

Boston Scientific Corporation

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: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291

Is this the product you have?

    • AMS 700 100 mL
    • Spherical Reservoir with InhibiZone
    • Part No. 72404156 -
  • Product Usageintended for use in the treatment of chronic, organic, male erectile dysfunction (impotence)
Lot codes and dates
  • Lot 24464037
Amount recalled
5

Where it was sold

Why it was recalled

A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 4, 2020 · Data as of Sep 19, 5:26 PM UTC

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