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).
FDA Recall Z-2045-2020 · Posted 2020-01-28
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeJCW
Date Initiated2019-12-17
Date Terminated2020-06-04
Product Quantity5
Reason for Recall
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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