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U.S. Department of Health and Human Services

Class 2 Device Recall Medrad(R) Sterile Disposable Stellant Syringe Kit

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  Class 2 Device Recall Medrad(R) Sterile Disposable Stellant Syringe Kit see related information
Date Initiated by Firm October 24, 2011
Date Posted November 02, 2011
Recall Status1 Terminated 3 on October 24, 2016
Recall Number Z-0147-2012
Recall Event ID 60240
510(K)Number K023183  
Product Classification Injector and syringe, angiographic - Product Code DXT
Product Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865.

Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy.
Code Information Catalog # SDS-CTP-SPK, Lot # 112865
Recalling Firm/
Manufacturer		 Medrad Inc
1 Medrad Dr
Indianola PA 15051-9759
For Additional Information Contact Kristi Carrico
724-940-6910
Manufacturer Reason
for Recall		 Packaging may exhibit open seals - sterility compromised
FDA Determined
Cause 2		 Packaging
Action Medrad sent a " Urgent Medical Device Recall letter" dated October 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed if they have any of the affected product lot, please contact MEDRAD customer support to make arrangements for the return of the product. Call 1 -800-633-7231, select option 5, then select option 1. Indicate that you are calling about the affected syringe kit recall. Complete and sign the attached response form and fax it back to MEDRAD at (412) 406-0942. Please complete and fax this form even if you do not have any of the referenced product so we can maintain proper accountability for all syring kits that have been shipped.
Quantity in Commerce 17,380
Distribution Nationwide Distribution -- including the States of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, VS, WA, WV, 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.
510(K) Database 510(K)s with Product Code = DXT and Original Applicant = MEDRAD, INC.
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