Recall Z-2002-2014— 3M Company - Health Care Business

Name: FDA recall Z-2002-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-09

Class II · Terminated

Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2014-06-09, terminated 2015-06-03. It names 2 FDA 510(k) clearances: K123546, K103277. 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.. Reason: 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..

Recalling firm: 3M Company - Health Care Business
Classification: Class II
Status: Terminated
Initiated: 2014-06-09
Terminated: 2015-06-03
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

2 on FDA's record

K123546 — 3M ATTEST(TM) AUTO-READER3M Company·cleared 2013-03-18
K103277 — 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER3M Company-3M Health Care·cleared 2011-04-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.