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Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT… recallZ-1954-2010 · Medrad Inc · initiated May 24, 2010

Terminated All recalls posted in July 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medrad Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1954-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 24, 2010
Posted by the FDA
Jul 9, 2010
Recalling firm
Medrad Inc
Quantity
1,382,889 kits
Product code
DXT
FDA submissions
K023183
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.

Product description

Stellant CT Dual Syringe Kits, Catalog Number SDS-CTP-QFT and SDS-CTP-SPK

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Other devices under the same FDA submission

15 devices cleared under K023183 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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