Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT… recallZ-0039-05 · Medrad Inc · initiated Oct 8, 2004
Terminated All recalls posted in October 2004
Is my device affected?
- 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.
- 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.
- 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
Sterility can be compromised by a component tearing the outer packaging
FDA root cause category: Other
What the company is doing
The recalling firm telephoned their customers on 10/8/04 to inform them of the problem and the need to return the product.
Recall details
- Recall number
- Z-0039-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 8, 2004
- Posted by the FDA
- Oct 22, 2004
- Recalling firm
- Medrad Inc
- Quantity
- 1650 kits
- Product code
- DXT
- FDA submissions
- K023183
- Distribution
- The product was shipped to medical facilities in AR, CA, CO, FL, LA, MI, NJ, NY, PA, and TX.
Product description
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Code information (models, lots, serial numbers)
Lot number 45535 exp 9/2008
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.
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPKBayer Medical Care Inc. · Injector And Syringe, Angiographic12 reports
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-SPKBayer Medical Care Inc. · Injector And Syringe, Angiographic11 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPKBayer Medical Care Inc. · Injector And Syringe, Angiographic8 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-QFTBayer Medical Care Inc. · Injector And Syringe, Angiographic6 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPKBayer Medical Care Inc. · Injector And Syringe, Angiographic6 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SCSBayer Medical Care Inc. · Injector And Syringe, Angiographic5 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-SPKBayer Medical Care Inc. · Injector And Syringe, Angiographic3 reports
- MEDRAD® Stellant Sterile Disposable Syringe SDS-CTP-QFTBayer Medical Care Inc. · Injector And Syringe, Angiographic2 reports
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-SPKBayer Medical Care Inc. · Injector And Syringe, Angiographic2 reports
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-QFTBayer Medical Care Inc. · Injector And Syringe, Angiographic1 report
- MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube SSS-LP-60Bayer Medical Care Inc. · Injector And Syringe, Angiographic1 report
- MEDRAD® Stellant Sterile Disposable Syringe SSS-CTP-SPKBayer Medical Care Inc. · Injector And Syringe, Angiographic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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