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

Recall Z-0631-2019 — Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

U.S. FDA — Device Enforcement · United States · 2018-10-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0631-2019
Date of alert: 2018-10-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardinal Health 200, LLC
Product category: device
Product type: Devices

Reported risk: Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.

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

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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.

Recall Z-0631-2019 — Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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