Z-2002-2014Class II

3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators...

Name: Z-2002-2014 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators...
Creator: 3M Company - Health Care Business
Published: 2014-06-09
License: https://open.fda.gov/license/

3M Company / initiated 2014-06-09 / Terminated / root cause: labeling and UDI

FDA source

3M Company - Health Care Business began a recall of 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... on 2014-06-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2002-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Posted: 2014-07-07
Terminated: 2015-06-03
Recalling firm: 3M Company
Product: 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.
Product code: FRC Indicator, Biological Sterilization Process
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 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.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2002-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2002-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-07

Product code FRC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)