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U.S. Department of Health and Human Services

Class 2 Device Recall AMS 700 100 mL Spherical Reservoir with InhibiZone

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  Class 2 Device Recall AMS 700 100 mL Spherical Reservoir with InhibiZone see related information
Date Initiated by Firm December 17, 2019
Date Posted January 28, 2020
Recall Status1 Terminated 3 on June 04, 2020
Recall Number Z-2045-2020
Recall Event ID 84739
Product Classification Prosthesis, penis, inflatable - Product Code JCW
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).
Code Information Lot 24464037
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
FDA Determined
Cause 2		 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 in Commerce 5
Distribution US Nationwide distribution including in the states of CA, MD, NC, NV, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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