Torosa Saline-Filled Testicular Prosthesis (Size Small)
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- November 9, 2021
- Terminated
- September 29, 2025
- Recall Number
- Z-0413-2022
- Quantity
- 19 units
- Firm Location
- Minneapolis, MN
Reason for Recall
Product is mislabeled for size.
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Lot / Code Info
SKU# 5206102400; Catalo # (450-1325); Lot 7685283
Root Cause
Process control
Action Taken
A customer letter was issued to affected consignees dated 11/09/2021. Consignees are asked to move all inventory to quarantine and returned all impacted product within 10 days of letter receipt. If the product was further distributed, the consignee is directed to notify downstream customers of the recall. An Acknowledgement and Receipt Form should be completed indicating the quantity that will be returned. This should be completed even if there is no inventory.
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