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
Product summary
- 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
incorrectly labeled