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U.S. Department of Health and Human Services

Class 2 Device Recall MEDRAD Sterile Disposable Syringe Kit

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  Class 2 Device Recall MEDRAD Sterile Disposable Syringe Kit see related information
Date Initiated by Firm January 29, 2009
Date Posted June 01, 2009
Recall Status1 Terminated 3 on June 04, 2009
Recall Number Z-1228-2009
Recall Event ID 51495
Product Classification amgiographic syringe - Product Code DXT
Product MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media.
Code Information catalog number DSK 130-Q. Lot number 72372
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Travis Deschamps
412-767-2400 Ext. 3412
Manufacturer Reason
for Recall		 Possible compromised sterility due to holes in styrene tray
FDA Determined
Cause 2		 Packaging process control
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.
Quantity in Commerce 2958 kits
Distribution Nationwide: AL, AZ, CA, FL, IL, LA, MA, MT, NC, NY, OH, TX, and WI.
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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