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

Recall Z-3079-2017 — MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.

U.S. FDA — Device Enforcement · China · 2017-06-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3079-2017
Date of alert
2017-06-01
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
Master & Frank (Pinghu) Co., Ltd.
Product category
device
Product type
Devices
Reported risk: The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
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.

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