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.
Reported: May 6, 2020 Initiated: April 10, 2019 #Z-1808-2020
Product Description
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.
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.
Details
- Recalling Firm
- Uromedica Inc.
- Units Affected
- 11 tool sets
- Distribution
- Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
- Location
- Plymouth, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Uromedica Inc.. Units affected: 11 tool sets.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1808-2020.
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