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

Recall Z-1445-2013 — I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

U.S. FDA — Device Enforcement · United States · 2012-06-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1445-2013
Date of alert: 2012-06-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: I-Flow LLC
Product category: device
Product type: Devices

Reported risk: I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

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

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Recall Z-1445-2013 — I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

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