Recall Z-1609-2023 ยท JOJ Indicator, Physical/Chemical Sterilization Process
3M Company - Health Care Business
3M Attest Steam Chemical Integrators, REF 1243A
| Date | May 18, 2023 (initiated Apr 6, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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 questi |
| Quantity | 16,229,000 units |
| 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220942 | 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) 3M Company, Jun 24, 2022 |