Z-1609-2023 Class II Ongoing
FDA device recall Z-1609-2023 was initiated by 3M Company - Health Care Business on April 6, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 16,229,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,229,000 units
Product Description
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 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.
Code Information
UDI/DI: Pouch: 30707387785735, (Shipper: 50707387785739), Lot Numbers: EP112025, EX112025, FE112025, EE122025, EM122025, EV122025, FD122025, EC012026, EM012026, ET012026