Recall Z-2045-2020 ยท JCW Prosthesis, Penis, Inflatable
Boston Scientific Corporation
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).
| Date | Jan 28, 2020 (initiated Dec 17, 2019) |
| Status | Terminated |
| Reason | A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone. |
| Root cause | Mixed-up of materials/components |
| Action | 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. |
| Quantity | 5 |
| Distribution | US Nationwide distribution including in the states of CA, MD, NC, NV, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.