Z-0830-2012

Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe...

Name: Z-0830-2012 Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe...
Creator: Mallinckrodt Inc
Published: 2011-10-11
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2011-10-11 / Terminated / root cause: packaging

FDA source

Mallinckrodt Inc began a recall of Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico... on 2011-10-11. The reason FDA records is "Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0830-2012
Status: Terminated
Initiated: 2011-10-11
Posted: 2012-01-20
Terminated: 2013-07-19
Recalling firm: Mallinckrodt, Inc.
Product: Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-Flarsheim Company, Cincinnati, OH The Liebel Flarsheim Illumena 150mL Syringes with Handi-Fil Straw are 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.
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 Illumena 150mL Syringe with Handi-Fil Straw, product 900101.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, Covidien, sent an "URGENT DEVICE RECALL" letter dated October 11, 2011 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to check their inventory, if any of the affected lots are found, discontinue use of the lots immediately; complete and return the BUSINESS RESPONSE FORM even if they do not have any of the affected lots via fax to (314) 654-8206 or email to [email protected] by October 28, 2011; return product and notify any consignees that this product may have been distributed to. If you have any questions about this recall, contact our Product Monitoring department at 800-778-7898.
Quantity in commerce: 187,400 units (900103 syringe: 129,200; 900101 syringe: 58,200)
Distribution: USA (nationwide) including states of: AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV; and countries of: Australia, Belgium, Brazil, Canada, Singapore, & Uruguay.
Product codes and lots: Catalog # 900103 - Lot # 0253304, Exp Date. 09/2013; Lot # 0298222, Exp Date 10/2013; Lot # 0298223, Exp Date 10/2013; Lot # 0308031, Exp Date 11/2013; Lot # 0312202, Exp Date 11/2013; Lot # 0330293, Exp Date 11/2013; Lot # 0344197, Exp Date 12/2013; Lot # 0351244, Exp Date 12/2013; Lot # 0351245, Exp Date 12/2013; Lot # 1007208, Exp Date 01/2013; Lot # 1014335, Exp Date 01/2013; Lot # 1126136, Exp Date 05/2013; Lot # 1175144, Exp Date 06/2013; Lot # 1189159, Exp Date 07/2013 & Lot # 1203154, Exp Date 07/2013. Catalog # 900101 - Lot #, 0314042, Exp Date, 11/2013; Lot #, 0323224, Exp Date, 11/2013; Lot #, 0356041, Exp Date, 12/2013; Lot #, 1007265, Exp Date, 01/2013; Lot #, 1119054, Exp Date, 04/2013 & Lot #, 1133140, Exp Date, 05/2013.

Product code IZQ

K781334Class IIDisposable Syringe Fill TubeMallinckrodt Group, Inc. / cleared 1978-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)