Summary
The FDA issued a Class II for 3M Attest Steam Chemical Integrators, REF 1243B by 3M Company - Health Care Business. 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 d.
Details
Source
Device Recall
External ID
Z-1610-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
3M Attest Steam Chemical Integrators, REF 1243B
Lot/Code Info: UDI/DI: Pouch: 30707387785742, (Shipper: 50707387785746), Lot Numbers: EG112025, ET012026
Quantity Affected: 2,235,000 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-06
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
3M Company - Health Care Business has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (3M Company - Health Care Business) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 3M Company - Health Care Business have FDA actions?
3M Company - Health Care Business has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1610-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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