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Custom Medical Specialties, Inc. recalls 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (
Recalled February 19, 2014 · FDA recall Z-0974-2014 · Custom Medical Specialties
Hazard
No endotoxin (LAL) testing to proper level. · FDA Class II
Units
2,610
Sold at
US Distribution including the states of CT, FL, IL, NJ, NY, PA, TN, VA and WI.
Description
No endotoxin (LAL) testing to proper level.
Product
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
Manufacturer(s)
Custom Medical Specialties, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →