Recall Z-1228-2009 ยท DXT Injector And Syringe, Angiographic
Medrad Inc
MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
| Date | Jun 1, 2009 (initiated Jan 29, 2009) |
| Status | Terminated |
| Reason | Possible compromised sterility due to holes in styrene tray |
| Root cause | Packaging process control |
| Action | On 1/29/09, Medrad issued an Urgent Medical Device Recall letter. Customers were requested to check their inventory for any of the affected batch. If the customer has affected product, they are instructed to contact the firm to make arrangement for the return of the product. Non responders were sent additional notifications via FedEx on 3/2/09 and 4/1/09. |
| Quantity | 2958 kits |
| Distribution | Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.