3M Attest Steam Chemical Integrators, REF 1243A
- Recall Initiated
- April 6, 2023
- Posted
- May 18, 2023
- Recall Number
- Z-1609-2023
- Quantity
- 16,229,000 units
- Firm Location
- Saint Paul, MN
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.
Lot / Code Info
UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, ET012026
Root Cause
Process control
Action Taken
3M issued an URGENT: Voluntary Product Recall to its consignees beginning 04/06/2023 via email or USPS certified mail. The notice explained the issue, hazard, and requested that the use of the affected product cease, identify any in stock product and dispose of it. The firm will replace the product. To request product replacement for affected lots disposed, contact 3M Health Care Customer Helpline at 1-800-228-3957, option #7 or by email to 3MFieldSafetyAction@montage72.com. Please note, replacement product can only be provided following 3M receipt of the completed form. If you have questions, please the 3M Health Care Customer Helpline at 1-800-228-3957, option #7.