Recall Z-2081-2012— Mallinckrodt Inc
Class II · Terminated
Class II FDA medical device recall by Mallinckrodt Inc, initiated 2010-02-01, terminated 2012-08-03. It names one FDA 510(k) clearance: K781334. 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.. 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..
- Recalling firm
- Mallinckrodt Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2010-02-01
- Terminated
- 2012-08-03
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.