3M Attest Steam Chemical Integrators, REF 1243B
FDA device recall Z-1610-2023 · posted 2023-05-18 · Open, Classified
Recall details
- Recalling firm
- 3M Company - Health Care Business
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- JOJ
- Quantity affected
- 2,235,000 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, In
- Date initiated
- 2023-04-06
- Date posted
- 2023-05-18
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) (K220942) | 3M Company | 2022-06-24 |