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

• Date Initiated by Firm: October 24, 2011
• Date Posted: November 02, 2011
• Recall Status: Terminated 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: 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