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

Recall Z-2446-2018 — Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800

U.S. FDA — Device Enforcement · France · 2018-05-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2446-2018
Date of alert: 2018-05-22
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: NewDeal SA
Product category: device
Product type: Devices

Reported risk: Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

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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