Device Recall 3M AttestTM Autoreader 의 리콜

Recall

68415

Class 2

Z-2002-2014

2014-06-09

2014-07-07

Terminated

United States

2015-06-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127541

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.