CLASS II Device recall · Reported 1 Aug 2012 · FDA Enforcement Report
The Handi-Fil Disposable Syringe Fill Tube is a sterile recalled
Mallinckrodt is recalling The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10, distributed nationwide in the US. The recall was initiated on 1 Feb 2010 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2081-2012
- FDA event ID
- 54724
- Recalling firm
- Mallinckrodt, Cincinnati, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Feb 2010
- FDA classified
- 26 Jul 2012
- Reported
- 1 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 1 Feb 2010 | Recall initiated by company | |
| 26 Jul 2012 | Classified by FDA | +906 days |
| 1 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoGeorgiaIllinoisKansasKentuckyLouisianaMarylandMichiganMinnesotaMissouriNorth CarolinaNebraskaNew JerseyNew YorkOhioOregonPennsylvaniaSouth Carolina
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #7159027 / Catalog #302050
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
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| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |