FDA recall Z-2045-2020

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).

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-12-17

Report date

2020-05-27

Termination date

2020-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2045-2020