3M Attest Steam Chemical Integrators, REF 1243B
FDA Recall Z-1610-2023 · Posted 2023-05-18
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Recalling Firm3M Company - Health Care Business
Recall StatusOpen, Classified
Product CodeJOJ
Date Initiated2023-04-06
Product Quantity2,235,000 units
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.
Firm 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 [email protected]. 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
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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