Recall Z-0974-2014 ยท KKX Drape, Surgical, Antimicrobial
Custom Medical Specialties, Inc.
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
| Date | Feb 12, 2014 (initiated Jul 12, 2013) |
| Status | Terminated |
| Reason | No endotoxin (LAL) testing to proper level. |
| Root cause | Under Investigation by firm |
| Action | 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 Administr |
| Quantity | 2,610 |
| Distribution | US Distribution including the states of CT, FL, IL, NJ, NY, PA, TN, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K882724 | MICROTEK PROBE DRAPE Microbio-Medics, Inc., Aug 3, 1988 |