Recall Z-2744-2016 ยท KKX Drape, Surgical, Antimicrobial
Ecolab Inc
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.
| Date | Jul 14, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 6750 eaches (675 cases) |
| Distribution | US: OH, NY, CA, MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.