| Class 2 Device Recall Stellant CT Dual Syringe Kits | |
Date Initiated by Firm | May 24, 2010 |
Date Posted | July 09, 2010 |
Recall Status1 |
Terminated 3 on October 13, 2010 |
Recall Number | Z-1954-2010 |
Recall Event ID |
55894 |
510(K)Number | K023183 |
Product Classification |
injector and syringe, angiographic - Product Code DXT
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Product | Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK |
Code Information |
99725, 99726, 99727, 99728, 99729, 99730, 99731, 99733, 99734, 99747, 99748, 99749, 99750, 99753, 99754, 99755, 99757, 99766, 99767, 99768, 99772, 99775, 99776, 99777, 99778, 99813, 100053, 100464, 100465, 100466, 100467, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100478, 100479, 100488, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100520, 100521, 100523, 100524, 100525, 100526, 100528, 100529, 100531, 100532, 100533, 100535, 100537, 100538, 100539, 100541, 100542, 100543, 100546, 100547, 100549, 100550, 100551, 100552, 100553, 100555, 100558, 100559, 100560, 100561, 100564, 100567, 100568, 100569, 100570, 100897, 101378, 101379, 101380, 101386, 101387, 101391, 101394 with exp dates between 2/2014 to 4/2014. |
Recalling Firm/ Manufacturer |
Medrad Inc 100 Global View Dr Warrendale PA 15086
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Manufacturer Reason for Recall | Kits contain a T connector that may be susceptible to cracking or breaking or leaking. This could cause product leakage or, less likely, patient injury. |
FDA Determined Cause 2 | Other |
Action | The recalling firm issued an Urgent Medical Device Field Correction on 5/24/10 requesting customers to check their inventory for the affected lots and complete the fax back form with the amount of product in stock. The manufacturer plans to make arrangements to provide individually packaged low-pressure connector tubing to use with the product in the event that cracking or breaking and leaking of the T connector is observed. This requires vigilance by the customers over the life of all of the devices.
For questions concerning this recall, please contact the company 1-800-633-7231, select option 2, and indicate that you are calling about the Stellant CT Dual Syringe Kit field correction. |
Quantity in Commerce | 1,382,889 kits |
Distribution | nationwide and Worldwide distribution includes AU, BE, BG, BM, BR, CA, CH, CI, CL, CN, CO, CS, DE, DK, EC, EG, FI, FR, GB, GT, HN, IN, IT, JM, JP, KW, KY, MU, MX, MY, NL, OM, PA, PH, PK, PR, SE, SG, TW, YE, ZA. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = DXT
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