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Terminated

ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.

FDA Recall Z-1808-2020 · Posted None

Recalling FirmUromedica Inc.
Recall StatusTerminated
Product CodeKOA
Date Initiated2019-04-10
Date Terminated2020-05-18
Product Quantity11 tool sets

Reason for Recall

Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.

Firm Action

Uromedica sent a notification to the customers via email and letter instructing them to identify the affected sets and returned them to Uromedica within 10 business days. Uromedica will provide for the return shipping of the affected tool set and replace if free of charge.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution to the following states: CA, GA, FL, MI, and VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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