Microtek Medical, Inc., Microscope Drape for Zeiss Standard Model/Catalog Number: 70890655 Product Description: The Micr
FDA device recall Z-0592-2011 · posted 2010-12-10 · Terminated
Recall details
- Recalling firm
- Microtek Medical, Inc.
- Reason for recall
- 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.
- Action taken
- 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. Legal at 1-888-844-0988.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 5 Cases, 12 drapes per case, 60 Drapes total distrubuted
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-08-23
- Date posted
- 2010-12-10
- Date terminated
- 2010-12-14
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROTEK EQUIPMENT DRAPES (K050322) | Microtek Medical, Inc. | 2005-05-17 |