PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 16, 2014 Initiated: June 9, 2014 #Z-2002-2014

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.

Details

Units Affected
5343 (2621 USA, 2722 OUS)
Distribution
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.
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by 3M Company - Health Care Business. Units affected: 5343 (2621 USA, 2722 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2014. Severity: Moderate. Recall number: Z-2002-2014.

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