Z-0353-2022 Class I Terminated
FDA device recall Z-0353-2022 was initiated by Covidien Llc on Nov 4, 2021 and is designated Class I. Reason for recall: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. The recall status is terminated (terminated Jul 9, 2024). Affected quantity: 278 total.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 15, 2021
- Initiation Date
- Nov 4, 2021
- Termination Date
- Jul 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 278 total
Product Description
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
Reason for Recall
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
GTIN/UDI - 10884521172531 Serial Numbers: 35B1700393 35B1700419 35B1700420 35B1700427 35B1700428 35B1700429 35B1700540 35B1700564 35B1700568 35B1700573 35B1800002
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0353-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026