Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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 in

U.S. FDA — Device Enforcement · United States · 2010-02-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2081-2012
Date of alert: 2010-02-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mallinckrodt Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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