Z-0815-2012

Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc...

Name: Z-0815-2012 Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc...
Creator: Mallinckrodt Inc
Published: 2011-12-20
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2011-12-20 / Terminated / root cause: packaging

FDA source

Mallinckrodt Inc began a recall of Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil... on 2011-12-20. The reason FDA records is "The firm received complaints from their customers stating that they found open seals on two of their sterilized products". 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-0815-2012
Status: Terminated
Initiated: 2011-12-20
Posted: 2012-01-19
Terminated: 2013-02-19
Recalling firm: Mallinckrodt, Inc.
Product: Handi-Fil Disposable Syringe Fill Tube P/N 302050, Plastic & Tyvec pouch, Mallinckrodt, Inc., Libel-Flarsheim, Cincinnati, OH Made in Mexico. The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve the projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: The firm received complaints from their customers stating that they found open seals on two of their sterilized products.
Root cause tag: packaging
FDA root cause: Packaging
Action: Mallinckrodt Inc. sent an "URGENT DEVICE RECALL" letter dated December 20, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product and to complete and return an attached Business Response form via fax to (314) 654-8206 or e-mail to [email protected]. Contact the Product Monitoring Department at 800-778-7898 for questions regarding this notice.
Quantity in commerce: 63,900 units
Distribution: Worldwide Distribution--USA (nationwide) including the states of AZ, CA, GA, IA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, WA, WI and WV and countries of Australia, Belgium, Canada, Japan and Singapore.
Product codes and lots: Catalog #302050, Lot # 9288021, Exp Date 10-2012; Lot # 0011122, Exp Date 01-2013; Lot # 0095256, Exp Date 04-2013; Lot # 0127196, Exp Date 05-2013; Lot # 0253137, Exp Date 09-2013 & Lot # 0302172, Exp Date 11-2013.

Product code DXT

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)