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Recall Observatory FDA recall evidence

Device product

3M Attest Steam Chemical Integrators, REF 1243A

Z-1609-2023

April 06, 2023

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 92041
Status
Ongoing
Classification
Class II
Quantity
16,229,000 units
Official record key
device-enforcement:Z-1609-2023

Official wording

Reason: 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.

Code information: UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, ET012026

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.