FDA recall Z-1609-2023

Product

3M Attest Steam Chemical Integrators, REF 1243A

Reason for recall

3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Austria, Australia, Bolivia, Brazil, Canada, Colombia, Czech Republic, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Vietnam.

Key facts

Status

Ongoing

Initiation date

2023-04-06

Report date

2023-05-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1609-2023