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Terminated

MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.

FDA Recall Z-0367-2011 · Posted 2010-11-15

Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2010-05-17
Date Terminated2010-11-17
Product Quantity39,448 syringe kits

Reason for Recall

Some kits have a hole in the packaging which could compromise the sterility of the components.

Firm Action

MEDRAD issued an URGENT MEDICAL DEVICE RECALL letter dated May 17, 2010, to all affected customers. The letter identified the product, the problem, and the action the customer should take. Customers were instructed to identify the product with the affected lot numbers. Contact MEDRAD Customer Support at 1-800-633-7231 to make arrangements for the return of the product. Complete and sign the form attached to the letter and fax it back to MEDRAD at 412-406-0942. For any questions regarding this recall call (412) 767-2400, ext 6851.

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution - USA including AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO MS, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Belgium, China, Columbia, Germany, Denmark, France, Great Britain, Hungary, Ireland, India, Israel, Italy, Mexico, Netherlands, Sweden, and Singapore.

Official Source

View FDA Recall →

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

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