Home / Recalls / ConvaTec, Inc / Z-0127-2023

Z-0127-2023 Class II Ongoing

Recalled by ConvaTec, Inc — Greensboro, NC

Recall Details

Product Type
Devices
Report Date
November 2, 2022
Initiation Date
August 16, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5284 units

Product Description

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.

Reason for Recall

impaired functionality of the release liner

Distribution Pattern

US Nationwide distribution.

Code Information

UDI/DI: 768455115358, Batch Numbers: 2A00585, 2A00586, 2A04528, 2A04529, 2A04530m

Other recalls by ConvaTec, Inc

  • Z-0160-2026 Class II — DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings (August 29, 2025)
  • Z-0903-2025 Class II — Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two- (November 29, 2024)
  • Z-1495-2024 Class II — ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control D (February 27, 2024)
  • Z-1350-2024 Class II — Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 42364 (February 19, 2024)
  • Z-1276-2024 Class II — ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, (January 17, 2024)
  • Z-0723-2023 Class II — ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive (November 15, 2022)
  • Z-0130-2023 Class II — ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400 (August 16, 2022)
  • Z-0129-2023 Class II — ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400 (August 16, 2022)
  • Z-0128-2023 Class II — ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 4 (August 16, 2022)
  • Z-1134-2022 Class II — SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains (April 22, 2022)