Z-2081-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 1, 2012
- Initiation Date
- February 1, 2010
- Termination Date
- August 3, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 cases (100 units per case)
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.
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.
Code Information
Lot #7159027 / Catalog #302050