Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
This recall has been terminated (originally issued July 9, 2010).
- Company
- Medrad Inc
- Recall Initiated
- May 24, 2010
- Posted
- July 9, 2010
- Terminated
- October 13, 2010
- Recall Number
- Z-1954-2010
- Quantity
- 1,382,889 kits
- Firm Location
- Warrendale, PA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.