| Date Initiated by Firm |
April 10, 2019 |
| Create Date |
April 28, 2020 |
| Recall Status1 |
Terminated 3 on May 18, 2020 |
| Recall Number |
Z-1808-2020 |
| Recall Event ID |
85486 |
| PMA Number |
P130018 |
| Product Classification |
Surgical instruments, g-u, manual (and accessories) - Product Code KOA
|
| Product |
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. |
| Code Information |
Model 750041, Lot # UM00650 |
Recalling Firm/
Manufacturer |
Uromedica Inc.
1840 Berkshire Ln N
Plymouth MN 55441-3723
|
| For Additional Information Contact |
Robert W. McLain
763-694-9880
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| 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. |
| Quantity in Commerce |
11 tool sets |
| Distribution |
Nationwide distribution to the following states: CA, GA, FL, MI, and VA. |
| 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.
|
