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Titan® inflatable penile prosthesis
Official notice
10 Nov 2023
Last checked
10 Nov 2023
An official Health Canada notice concerns Titan® inflatable penile prosthesis. Pump bulbs are manufactured using 2 molds. A component on one of the two molds shifted during production. This resulted in a gradual build of material on the mold, which gradually decreased wall thickness of the pump. This occurred over the course of several weeks, culminating in a period of time (17 September 2022 to 02 December 2022) where pump bulbs were manufactured below the wall thickness specification. Recall Start Date: October 30, 2023 Published 2023-11-10.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74577
Official notice
2023-11-10
The hazard
The hazard
Pump bulbs are manufactured using 2 molds. A component on one of the two molds shifted during production. This resulted in a gradual build of material on the mold, which gradually decreased wall thickness of the pump. This occurred over the course of several weeks, culminating in a period of time (17 September 2022 to 02 December 2022) where pump bulbs were manufactured below the wall thickness specification. Recall Start Date: October 30, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Coloplast A S, Titan® Inflatable Penile Prosthesis.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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