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

Recall Z-0228-2018 — Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.025), REF/Product Code RM*RS6J10PA, STERILE, Rx ONLY

U.S. FDA — Device Enforcement · United States · 2017-06-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0228-2018
Date of alert
2017-06-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Terumo Medical Corp
Product category
device
Product type
Devices
Reported risk: An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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