The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube — Class II medical device recall Z-2081-2012
Terminated recall by Mallinckrodt Inc, reported 2012-08-01, distributed nationwide. A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that
| Recall number | Z-2081-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mallinckrodt Inc, Cincinnati, OH, United States |
| Recall initiated | 2010-02-01 |
| Classified | 2012-07-26 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2012-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, JP, SG |
| Lot numbers | 7159027 |
| Model numbers | 302050 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2081-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.