FDA recall Z-1134-2022

Product

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

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2022-04-22

Report date

2022-06-01

Termination date

2026-03-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2022