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3M Company – Health Care Business Recall 92041

Description: 3M Attest Steam Chemical Integrators, REF 1243B

3M Company – Health Care Business Recall 92041 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1610-2023
Event ID92041
Event Description3M Attest Steam Chemical Integrators, REF 1243B
Product TypeDevices
DistributionWorldwide 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.
Quantity2,235,000 units
Recall Reason3M 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.
Device Classification20230524
Device Code InfoUDI/DI: Pouch: 30707387785742, (Shipper: 50707387785746), Lot Numbers: EG112025, ET012026
Center Classification Date20230518
Recall Initiation Date20230406
Recalling Firm3M Company - Health Care Business
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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