Recall Z-2866-2011 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures.
| Date | Jul 22, 2011 (initiated Jun 2, 2011) |
| Status | Terminated |
| Reason | Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embo |
| Root cause | Device Design |
| Action | Medrad Inc., sent two types of "MEDICAL DEVICE FIELD CORRECTION" notifications on June 2, 2011 to all affected customers. 1. To those customers who Avanta Systems have already undergone market withdrawal and thus have been upgraded, the notification provided customer awareness that prior action should be considered a field correction. The letter stated that NO action is required since their system(s) has already been upgraded. If you have any questions, concerning these activities contact the Director of Quality Systems at (724) 940-6905. 2. To those customers whose Avanta Systems have |
| Quantity | 842 |
| Distribution | Worldwide Distribution -- (USA) (nationwide) including the state of Puerto Ricoand the countries of: AE, AL, AT, BE, BG, BR, CA, CH, CO, CY, DE, DK, DO, ES, FI, FR, GB, HK, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LY, MA, MT, MX, MY, NL, PA, PH, PK, PT, QA, RS, RU, SA, SE, SG, SI, TR, VI, and ZA. |
| 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 |