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

Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Pro — recall Z-0724-2017

U.S. FDA — Device Enforcement · United States · 2016-11-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0724-2017
Date of alert: 2016-11-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Halyard Health, Inc
Product category: device
Product type: Devices

Reported risk: Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.

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

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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