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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Sterile Disposable Syringe Kit Recall

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  Class 2 Device Recall MEDRAD Sterile Disposable Syringe Kit Recall see related information
Date Initiated by Firm May 17, 2010
Date Posted November 15, 2010
Recall Status1 Terminated 3 on November 17, 2010
Recall Number Z-0367-2011
Recall Event ID 55839
Product Classification Injector and syringe, angiographic - Product Code DXT
Product 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.
Code Information Lot Numbers 96501 exp 11/2014 and 96502 exp 11/2014
Recalling Firm/
Manufacturer		 Medrad Inc
100 Global View Dr
Warrendale PA 15086
For Additional Information Contact Alison Gerlach
412-767-2400 Ext. 6851
Manufacturer Reason
for Recall		 Some kits have a hole in the packaging which could compromise the sterility of the components.
FDA Determined
Cause 2		 Packaging
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.
Quantity in Commerce 39,448 syringe kits
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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