Z-2045-2020 Class II Terminated
FDA device recall Z-2045-2020 was initiated by Boston Scientific Corporation on December 17, 2019 and is designated Class II. Reason for recall: A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone. The recall status is terminated (terminated June 4, 2020). Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- December 17, 2019
- Termination Date
- June 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
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.
Distribution Pattern
US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
Code Information
Lot 24464037