The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in ...
FDA Recall #Z-2081-2012 — Class II — February 1, 2010
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.
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.
Recalling Firm
Mallinckrodt Inc — Cincinnati, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Lot #7159027 / Catalog #302050
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated