ConvaTec, Inc: Medical Device Recall in 2022 - (Recall #: Z-1134-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.

Product Classification:

Class II

Date Initiated: April 22, 2022

Date Posted: June 1, 2022

Recall Number: Z-1134-2022

Event ID: 90041

Reason for Recall:

Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

Status: Terminated

Product Quantity: 600 market units

Code Information:

Product order number: ICC 413157; LOT Number 1H02899; Expiration Date: Aug 2026; DI Number: 00768455106189

Distribution Pattern:

Distributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL, DE, KY, WA, KS, MN, MS and internationally to India.

Voluntary or Mandated:

Voluntary: Firm initiated