Recall Z-1228-2009
Medrad Inc · initiated January 29, 2009
Product
MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
Codes / lots: catalog number DSK 130-Q. Lot number 72372
Reason for recall
Possible compromised sterility due to holes in styrene tray
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-1228-2009
- Initiated
- January 29, 2009
- Posted by FDA
- June 1, 2009
- Terminated
- June 4, 2009
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 2958 kits
- Distribution
- Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.
- Recalling firm
- Medrad Inc, Indianola, PA