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.
Recall
- Recall Number
- Z-2002-2014
- Event Number
- 68415
- Firm
- 3M Company Health Care Business 3M Center
- FEI Number
- 2110898
- Product Code
- FRC
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- June 9, 2014
- Posted
- July 7, 2014
- Terminated
- June 3, 2015
- Address
- 2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144
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.
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.
Consignees were sent on 6/9/2014 a 3M "Urgent Medical Devices Correction" letter dated May 21, 2014. The letter described the problem and the product involved in the recall. The letter described what action is 3M taking and what action was required of the consignees. Consignees were sent an adhesive label and a response card. They requested consignees to adhere the label to a portion of the plastic covering each unit in a location where it is visible to the end-user. After that, they are requested to fill out and return the response card.
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.
5343 (2621 USA, 2722 OUS)