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
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
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.