Recall Z-0147-2012 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy.
| Date | Nov 2, 2011 (initiated Oct 24, 2011) |
| Status | Terminated |
| Reason | Packaging may exhibit open seals - sterility compromised |
| Root cause | Packaging |
| Action | Medrad sent a " Urgent Medical Device Recall letter" dated October 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed if they have any of the affected product lot, please contact MEDRAD customer support to make arrangements for the return of the product. Call 1 -800-633-7231, select option 5, then select option 1. Indicate that you are calling about the affected syringe kit recall. Complete and sign the attached response form and fax it back to MEDRAD at (412) 406-0942. Please |
| Quantity | 17,380 |
| Distribution | Nationwide Distribution -- including the States of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, VS, WA, WV, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM Medrad, Inc., Jan 10, 2003 |