FDA recall Z-2330-2018

Product

Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

Reason for recall

The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.

Distribution

Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.

Key facts

Status

Terminated

Initiation date

2012-06-18

Report date

2018-07-04

Termination date

2020-05-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Clarkston, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2018