Recall Z-0592-2011 ยท KKX Drape, Surgical, Antimicrobial
Microtek Medical, Inc.
Microtek Medical, Inc., Microscope Drape for Zeiss Standard Model/Catalog Number: 70890655 Product Description: The Microtek Medical, Inc., Microscope Drape for Zeiss Standard is intended is to protect surgical microscopes from contamination during various procedures. Labeling for the product is as follows: (1.) INNER CARTON LABEL: Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDAR
| Date | Dec 10, 2010 (initiated Aug 23, 2010) |
| Status | Terminated |
| Reason | This product is being recalled due the product is miss-labeled as being sterilized by EO processing; however, the product was processed using Gamma sterilization. |
| Root cause | Error in labeling |
| Action | On 08/23/10 Microtek Medical, Inc., Jacksonville, Florida notified all of their customers via a telephone call and requested immediate return of the product . The firm followed up with each of the customers by sending out an Urgent: Medical Device Recall letter (written notice), dated September 02,2010, to each on 9/8/10. The letter identified the affected product, stated the reason for the recall, and asked that the product be returned immediately. Customers are to complete and return the enclosed response form. Anyone needing further assistance is asked to contact Elizabeth Jolly, V.P. |
| Quantity | 5 Cases, 12 drapes per case, 60 Drapes total distrubuted |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050322 | MICROTEK EQUIPMENT DRAPES Microtek Medical, Inc., May 17, 2005 |