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U.S. Department of Health and Human Services

Class 2 Device Recall 3M Attest

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  Class 2 Device Recall 3M Attest see related information
Date Initiated by Firm April 06, 2023
Date Posted May 18, 2023
Recall Status1 Open3, Classified
Recall Number Z-1610-2023
Recall Event ID 92041
510(K)Number K220942  
Product Classification Indicator, physical/chemical sterilization process - Product Code JOJ
Product 3M Attest Steam Chemical Integrators, REF 1243B
Code Information UDI/DI: Pouch: 30707387785742, (Shipper: 50707387785746), Lot Numbers: EG112025, ET012026
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave
Bldg 275-5w-06
Saint Paul MN 55144-0001
For Additional Information Contact Jennifer Ehrlich
651-592-0132
Manufacturer 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.
FDA Determined
Cause 2		 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 questions, please the 3M Health Care Customer Helpline at 1-800-228-3957, option #7.
Quantity in Commerce 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, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Poland, Saudi Arabia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JOJ and Original Applicant = 3M Company
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