Angiomat Illumena Syringe, 150mL Linden Luer Syringe with… recallZ-2859-2011 · Mallinckrodt Inc · initiated May 20, 2011
Terminated All recalls posted in July 2011
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 Mallinckrodt 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
Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.
FDA root cause category: Other
What the company is doing
COVIDIEN sent an Urgent Device Recall letter dated May 20, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use the attached business response form and report the quantity of lot number 0253304 currently in their stock. If the customer did not have any of the affected lot they were to indicate by checking the appropriate box on the form. When completed, customers were asked to fax to (314) 654-8206 or email to [email protected]. All product from lot number 0253304 was to be returned to Covidien. Once the business notification form is received a Return Goods Authorization for the quantity of product reported will be sent to the customer. Customers would receive credit for all return product from affected lot. For any questions regarding this recall customers were asked to contact the Product Monitoring department at 800-778-7898. For questions about credit for the product, call Customer Service at 888-744-1414, menu option 1, and then menu option 2.
Recall details
- Recall number
- Z-2859-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 20, 2011
- Posted by the FDA
- Jul 21, 2011
- Recalling firm
- Mallinckrodt Inc
- Quantity
- 11,000 units (200 cases/50 units per case)
- Product code
- IZQ
- FDA submissions
- K963071
- Distribution
- Worldwide Distribution - USA including CA, FL, IL, IN, MI, MO, NY, OH, TN & TX. and the country of Australia.
Product description
Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray. The Liebel Flarsheim Illumena 150 mL Linden Luer Syringe with Handi-Fil Straw is designed for use with the Illumena Injector System. The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
Code information (models, lots, serial numbers)
Lot number - 0253304, Part No. 900103
Other devices under the same FDA submission
2 devices cleared under K963071 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LF 900001CLiebel-Flarsheim Company LLC · Injector And Syringe, Angiographic5 reports
- LF 900006CLiebel-Flarsheim Company LLC · Injector And Syringe, Angiographic2 reports
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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