FDA Device

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Hazard

Product is mislabeled for size.

What You Should Do

Remedy

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.

Products

Torosa Saline-Filled Testicular Prosthesis (Size Small)
Brand
Coloplast Manufacturing US, LLC
UPC
SKU# 5206102400; Catalo # (450-1325); Lot 7685283

Units Affected

19 units