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

PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the — recall Z-1136-2014

U.S. FDA — Device Enforcement · United States · 2014-01-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1136-2014
Date of alert: 2014-01-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: KCI USA, INC.
Product category: device
Product type: Devices

Reported risk: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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