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

Recall Z-0208-2018 — Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Pa

U.S. FDA — Device Enforcement · United States · 2017-04-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0208-2018
Date of alert: 2017-04-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Intersurgical Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 31402822

Reported risk: A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff is over-inflated.

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.

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.

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