PlainRecalls
FDA Devices Moderate Class II Ongoing

3M Attest Steam Chemical Integrators, REF 1243B

Reported: May 24, 2023 Initiated: April 6, 2023 #Z-1610-2023

Product Description

3M Attest Steam Chemical Integrators, REF 1243B

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.

Details

Units Affected
2,235,000 units
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.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
3M Attest Steam Chemical Integrators, REF 1243B. Recalled by 3M Company - Health Care Business. Units affected: 2,235,000 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 24, 2023. Severity: Moderate. Recall number: Z-1610-2023.