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

Recall Z-0117-2018 — Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.

U.S. FDA — Device Enforcement · United States · 2017-10-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0117-2018
Date of alert
2017-10-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Halyard Health, Inc
Product category
device
Product type
Devices
Reported risk: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.
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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