Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 1, 2012
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Mallinckrodt Inc recalled The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 in… - a moderate-severity action.
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 in… was recalled by Mallinckrodt Inc in August 1, 2012. Reason: A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that…. Check the official notice for the remedy. Verify recall #Z-2081-2012 with the FDA Devices before acting.
The recall
Mallinckrodt Inc issued this moderate-severity FDA Devices recall-A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that….
- Moderate
- severity level
- Class II
- classification
- August 1, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2081-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2081-2012) was formally reported on August 1, 2012, with the manufacturer initiating the action on February 1, 2010. It is classified under Moderate severity (Class II), with a current status of Terminated. Mallinckrodt Inc is listed as the recalling firm, operating out of Cincinnati, OH. Federal records list the affected scope as 75 cases (100 units per case).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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,…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
75 cases (100 units per case)
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2081-2012 |
| Date reported | August 1, 2012 |
| Date initiated | February 1, 2010 |
| Recalling firm | Mallinckrodt Inc |
| Firm location | Cincinnati, OH |
| Affected scope | 75 cases (100 units per case) |
| Distribution | 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 & SIN… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2081-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mallinckrodt Inc. Units affected: 75 cases (100 units per case).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2081-2012.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2081-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 1, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.