FDA-Device2020-05-27Class II
AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
Boston Scientific Corporation
Hazard
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
Sold states
US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
Affected count
5
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2045-2020Don't want to check this manually?
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