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Recall Observatory FDA recall evidence

Device product

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).

Z-2045-2020

December 17, 2019

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 84739
Status
Terminated
Classification
Class II
Quantity
5
Official record key
device-enforcement:Z-2045-2020

Official wording

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

Code information: Lot 24464037

Distribution pattern: US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled