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

Recall Z-1518-2020 — Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

U.S. FDA — Device Enforcement · United States · 2020-02-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1518-2020
Date of alert: 2020-02-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Avid Medical, Inc.
Product category: device
Product type: Devices

Reported risk: The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

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-1518-2020 — Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

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