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).
This recall has been terminated (originally issued January 28, 2020).
- Company
- Boston Scientific Corporation
- Recall Initiated
- December 17, 2019
- Posted
- January 28, 2020
- Terminated
- June 4, 2020
- Recall Number
- Z-2045-2020
- Quantity
- 5
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot 24464037
Root Cause
Mixed-up of materials/components
Action Taken
On December 17, 2019, the firm sent an Urgent Medical Device Product Advisory letter to affected customers. Customers were informed of the labeling mix-up and instructed to add the advisory notice to the patient record. Customers were also asked to complete and returned an enclosed acknowledgement form. Customers with questions should contact their local Sales Representative.