Z-2002-2014 Class II Terminated
FDA device recall Z-2002-2014 was initiated by 3M Company - Health Care Business on Jun 9, 2014 and is designated Class II. Reason for recall: Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for… The recall status is terminated (terminated Jun 3, 2015). Affected quantity: 5343 (2621 USA, 2722 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Jul 16, 2014
- Initiation Date
- Jun 9, 2014
- Termination Date
- Jun 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5343 (2621 USA, 2722 OUS)
Product Description
3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
Reason for Recall
Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.
Code Information
All serial numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2002-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026