Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK
FDA Recall Z-1954-2010 · Posted 2010-07-09
Recalling FirmMedrad Inc
Recall StatusTerminated
Product CodeDXT
Date Initiated2010-05-24
Date Terminated2010-10-13
Product Quantity1,382,889 kits
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.