5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover

No endotoxin (LAL) testing to proper level.

Microtek - Ecolab sent a Urgent Medical Device Recall Letter dated July 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that you purchased this product CMS-6049 and this recall is dating back as far was 2008. Attached is a list affected lot number, however, all lots of the CMS-6049 are being recalled. Please inspect your inventory and return any product to us. To prevent any potential patient harm, discontinue the use of the probe cover. In order to advise the Food and Drug Administration about the effectiveness of this recall, you are requested to complete and return the enclosed questionnaire promptly fax or email it no later than July 29, 2013. It is necessary to report to us even if all products have been used. Any product still in your inventory is to be returned to us using a Return Authorization Number and our shipping number which will be given to you by calling (919) 202-8462Ext. 205.