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

Recall Z-0341-2022 — Puritan Bennett 980 Series Ventilator, 980S3ENDICU

U.S. FDA — Device Enforcement · United States · 2021-11-04 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0341-2022
Date of alert
2021-11-04
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Covidien Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884521171244
Reported risk: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
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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