Coloplast Manufacturing US, LLC Recall 89029
Description: Torosa Saline-Filled Testicular Prosthesis (Size Small)
Coloplast Manufacturing US, LLC Recall 89029 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0413-2022 |
| Event ID | 89029 |
| Event Description | Torosa Saline-Filled Testicular Prosthesis (Size Small) |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Canada. |
| Quantity | 19 units |
| Recall Reason | Product is mislabeled for size. |
| Device Classification | 20211229 |
| Device Code Info | SKU# 5206102400; Catalo # (450-1325); Lot 7685283 |
| Center Classification Date | 20211222 |
| Recall Initiation Date | 20211109 |
| Recalling Firm | Coloplast Manufacturing US, LLC |
| Initial Notification | Letter |
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