Home / Recalls / Coloplast Manufacturing US, LLC / Z-1374-2023

Z-1374-2023 Class II Ongoing

Recalled by Coloplast Manufacturing US, LLC — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
April 19, 2023
Initiation Date
March 1, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 units

Product Description

Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis

Reason for Recall

XXX

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.

Code Information

UDI/DI 05708932487368, Lot Numbers: 8849601, 8849600, 8849621

Other recalls by Coloplast Manufacturing US, LLC

  • Z-0844-2025 Class II — Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA611 (December 2, 2024)
  • Z-0845-2025 Class II — X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, (December 2, 2024)
  • Z-1463-2024 Class II — Ureteral dilator, REF RBD014 (March 11, 2024)
  • Z-1372-2023 Class II — Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prost (March 1, 2023)
  • Z-1370-2023 Class II — Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Pro (March 1, 2023)
  • Z-1364-2023 Class II — Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Pro (March 1, 2023)
  • Z-1366-2023 Class II — Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Pro (March 1, 2023)
  • Z-1363-2023 Class II — Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Pro (March 1, 2023)
  • Z-1362-2023 Class II — Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Pros (March 1, 2023)
  • Z-1371-2023 Class II — Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Pro (March 1, 2023)