FDAFDA · Food and drugs·Recall number Z-1808-2020
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.
Published May 6, 2020 · Recall initiated: April 10, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Uromedica Inc.
- Distributor
- Nationwide distribution to the following states: CA, GA, FL, MI, and VA.
- Lot
- Model 750041, Lot # UM00650
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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