FDA Recall
Terminated
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
Recall: Z-2744-2016
·
Initiated July 14, 2016
Recall
- Recall Number
- Z-2744-2016
- Event Number
- 74710
- Firm
- Ecolab Inc
- FEI Number
- 1000289767
- Product Code
- KKX
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- July 14, 2016
- Terminated
- November 2, 2016
- Address
- 370 Wabasha St N, Saint Paul, MN, 55102-1323
Description
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
Reason
Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.
Action
Consignees were sent on 7/14/2016 an Ecolab "Urgent Medical Device Recall" letter dated July 14, 2016. The letter described the problem and the product involved in the recall. Advised consignees to immediately quarantine the product and to notify their customers. For questions contact Customer Service at 1-800-824-3027.
Distribution
US: OH, NY, CA, MN.
Quantity
6750 eaches (675 cases)