Recall Z-0346-2022— Covidien Llc
Class I · Terminated
Class I FDA medical device recall by Covidien Llc, initiated 2021-11-04, terminated 2024-07-09. It names one FDA 510(k) clearance: K193056. Product: Puritan Bennett 980 Series Ventilator, 980X1ENDIPC. Reason: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use..
- Recalling firm
- Covidien Llc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-11-04
- Terminated
- 2024-07-09
- Firm location
- Mansfield, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.