Z-2081-2012Class II

The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with...

Name: Z-2081-2012 The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with...
Creator: Mallinckrodt Inc
Published: 2010-02-01
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2010-02-01 / Terminated / root cause: packaging

FDA source

Mallinckrodt Inc began a recall of The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward... on 2010-02-01. FDA classified it as Class II and gives the reason as "A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed". 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-2081-2012
Classification: Class II
Status: Terminated
Initiated: 2010-02-01
Posted: 2012-07-26
Terminated: 2012-08-03
Recalling firm: Mallinckrodt, Inc.
Product: The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that 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: A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Covidien send an Urgent Device Recall letter dated February 1, 2010, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and discontinue use of the product immediately. Customers were asked to complete the attached business form and report the quantity of affected product currently in their stock. Once the form is completed customers should fax the form to 314-654-8206. Once the business notification form is received, an RGA number will be sent to the customer for return of the product. Customers will receive credit for all returned product. For questions regarding this recall call the Product Monitoring Department at 800-778-7898. For questions about credit for the product, please call Customer Service at 888-774-1414, menu option 1, then menu option 2. For questions regarding this recall call 513-948-5719.
Quantity in commerce: 75 cases (100 units per case)
Distribution: Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, GA, IL, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WI, & WV and countries including: AUSTRALIA, BELGIUM, BRAZIL, CANADA, JAPAN & SINGAPORE.
Product codes and lots: Lot #7159027 / Catalog #302050

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2081-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2081-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26

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)