Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2081-2012

February 01, 2010

Class II

Product summary

Firm
Mallinckrodt Inc
Event
Event 54724
Status
Terminated
Classification
Class II
Quantity
75 cases (100 units per case)
Official record key
device-enforcement:Z-2081-2012

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.