3M Company – Health Care Business Recall 92041
Description: 3M Attest Steam Chemical Integrators, REF 1243B
3M Company – Health Care Business Recall 92041 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1610-2023 |
| Event ID | 92041 |
| Event Description | 3M Attest Steam Chemical Integrators, REF 1243B |
| Product Type | Devices |
| 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. |
| Quantity | 2,235,000 units |
| Recall 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. |
| Device Classification | 20230524 |
| Device Code Info | UDI/DI: Pouch: 30707387785742, (Shipper: 50707387785746), Lot Numbers: EG112025, ET012026 |
| Center Classification Date | 20230518 |
| Recall Initiation Date | 20230406 |
| Recalling Firm | 3M Company - Health Care Business |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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