FDA Device recall Z-2081-2012
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that proje…
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that proje… by Mallinckrodt, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2081-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-02-01 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Mallinckrodt |
| Distribution | US |
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.
Identifiers
| code_info | Lot #7159027 / Catalog #302050 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2081-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.