FDAFDA · Food and drugs·Recall number Z-2081-2012
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.
Published August 1, 2012 · Recall initiated: February 1, 2010
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mallinckrodt Inc
- Distributor
- 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.
- Lot
- Lot #7159027 / Catalog #302050
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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