| New Search | Back to Search Results |
| | Class 2 Device Recall 3M AttestTM Autoreader |
| Date Initiated by Firm | June 09, 2014 |
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| Date Posted | July 07, 2014 |
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| Recall Status1 | Terminated 3 on June 03, 2015 |
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| Z-2002-2014 |
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| Recall Event ID | 68415 |
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Indicator, biological sterilization process - Product CodeFRC
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| 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.
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| Code Information | All serial numbers. |
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Recalling Firm/
Manufacturer | 3M Company - Health Care Business
3M Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144
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| For Additional Information Contact | 3M Health Care Helpline
800-228-3957 |
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| 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. |
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| Labeling Change Control |
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| 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. |
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| 5343 (2621 USA, 2722 OUS) |
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| 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. |
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| TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. | | 510(K) Database | 510(K)s with Product Code = FRC and Original Applicant = 3M COMPANY
510(K)s with Product Code = FRC and Original Applicant = 3M COMPANY-3M HEALTH CARE
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