Recall Z-0870-2013 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
| Date | Feb 21, 2013 (initiated Nov 5, 2012) |
| Status | Terminated |
| Reason | The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory. |
| Root cause | Packaging |
| Action | Medrad sent a Recall letter dated November 5, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were instructed to review their inventory and quarantine any packages with an expiration date prior to April, 2017. Customers were also given the option of conducting a visual inspection on site to determine if the product should be returned. Alternatively, the customer has the option of returning the affected product. If the customer has affected product, they are instructed to contact Medrad Customer Su |
| Quantity | 832,175 |
| Distribution | Worldwide Distribution including USA nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050456 | MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM Medrad, Inc., Jun 17, 2005 |