Uromedica Inc. Recall 89184
Description: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Uromedica Inc. Recall 89184 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0458-2022 |
| Event ID | 89184 |
| Event Description | UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, KS, MD, TX, and WI. |
| Quantity | 18 devices |
| Recall Reason | The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure. |
| Device Classification | 20220112 |
| Device Code Info | Lot numbers UM00794 and UM00817, UDI 00180668000106 |
| Center Classification Date | 20220105 |
| Recall Initiation Date | 20211122 |
| Recalling Firm | Uromedica Inc. |
| Initial Notification | Letter |
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