510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2859-2011

Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded...

Mallinckrodt, Inc. / initiated 2011-05-20 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Mallinckrodt Inc began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-2859-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Mallinckrodt, Inc.
Product
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.
Product code
IZQ Injector, Contrast Medium, Automatic
Reason for recall
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.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
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.
Quantity in commerce
11,000 units (200 cases/50 units per case)
Distribution
Worldwide Distribution - USA including CA, FL, IL, IN, MI, MO, NY, OH, TN & TX. and the country of Australia.
Product codes and lots
Lot number - 0253304, Part No. 900103