Mallinckrodt Inc: Medical Device Recall in 2012 - (Recall #: Z-2081-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 1, 2010

Date Posted: August 1, 2012

Recall Number: Z-2081-2012

Event ID: 54724

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.

Status: Terminated

Product Quantity: 75 cases (100 units per case)

Code Information:

Lot #7159027 / Catalog #302050

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated