AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended ...
FDA Recall #Z-2045-2020 — Class II — December 17, 2019
Product Description
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).
Reason for Recall
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5
Distribution
US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
Code Information
Lot 24464037
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated