Recall Z-1954-2010 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
| Date | Jul 9, 2010 (initiated May 24, 2010) |
| Status | Terminated |
| Reason | Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury. |
| Root cause | Other |
| Action | The recalling firm issued an Urgent Medical Device Field Correction on 5/24/10 requesting customers to check their inventory for the affected lots and complete the fax back form with the amount of product in stock. The manufacturer plans to make arrangements to provide individually packaged low-pressure connector tubing to use with the product in the event that cracking or breaking and leaking of the T connector is observed. This requires vigilance by the customers over the life of all of the devices. For questions concerning this recall, please contact the company 1-800-633-7231, select op |
| Quantity | 1,382,889 kits |
| Distribution | nationwide and Worldwide distribution includes AU, BE, BG, BM, BR, CA, CH, CI, CL, CN, CO, CS, DE, DK, EC, EG, FI, FR, GB, GT, HN, IN, IT, JM, JP, KW, KY, MU, MX, MY, NL, OM, PA, PH, PK, PR, SE, SG, TW, YE, ZA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM Medrad, Inc., Jan 10, 2003 |