Medical device recalls Moderate risk

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

Recall date
December 17, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2045-2020
FDA classification
Class II
Brand / firm
Boston Scientific Corporation
Sold / distributed
US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).

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