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Terminated

MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.

FDA Recall Z-1228-2009 · Posted 2009-06-01

Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2009-01-29
Date Terminated2009-06-04
Product Quantity2958 kits

Reason for Recall

Possible compromised sterility due to holes in styrene tray

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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