MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
This recall has been terminated (originally issued June 1, 2009).
- Company
- Medrad Inc
- Recall Initiated
- January 29, 2009
- Posted
- June 1, 2009
- Terminated
- June 4, 2009
- Recall Number
- Z-1228-2009
- Quantity
- 2958 kits
- Firm Location
- Indianola, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Possible compromised sterility due to holes in styrene tray
Distribution
Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.
Lot / Code Info
catalog number DSK 130-Q. Lot number 72372
Root 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.
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