Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
FDA device recall Z-1954-2010 · posted 2010-07-09 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 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, T
- Date initiated
- 2010-05-24
- Date posted
- 2010-07-09
- Date terminated
- 2010-10-13
- Location
- Warrendale, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD STELLANT CT INJECTOR SYSTEM (K023183) | Medrad, Inc. | 2003-01-10 |