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.
This recall has been terminated (originally issued November 15, 2010).
- Company
- Medrad Inc
- Recall Initiated
- May 17, 2010
- Posted
- November 15, 2010
- Terminated
- November 17, 2010
- Recall Number
- Z-0367-2011
- Quantity
- 39,448 syringe kits
- Firm Location
- Warrendale, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Some kits have a hole in the packaging which could compromise the sterility of the components.
Distribution
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.
Lot / Code Info
Lot Numbers 96501 exp 11/2014 and 96502 exp 11/2014
Root Cause
Packaging
Action Taken
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.