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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012

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Event Detail

Event ID 54724
Product Type Devices
Status Completed
Recalling Firm Mallinckrodt Inc
City Cincinnati
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-02-01
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #7159027 / Catalog #302050 Class II 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. 75 cases (100 units per case) Z-2081-2012