Reported Aug 1, 2012 · Terminated
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J"…
Mallinckrodt Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mallinckrodt Inc · 2111 E Galbraith Rd · Cincinnati, OH · 45237-1624
Is this the product you have?
- 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 codes and dates
- Lot #7159027 / Catalog #302050
- Amount recalled
- 75 cases (100 units per case)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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