MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
FDA device recall Z-1228-2009 · posted 2009-06-01 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- Possible compromised sterility due to holes in styrene tray
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 2958 kits
- Distribution
- Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.
- Date initiated
- 2009-01-29
- Date posted
- 2009-06-01
- Date terminated
- 2009-06-04
- Location
- Indianola, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.