FDAFDA · Food and drugs·Recall number Z-2002-2014
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.
Published July 16, 2014 · Recall initiated: June 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- 3M Company - Health Care Business
- Distributor
- 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.
- Lot
- All serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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