Recalls / —
—#189265
Product
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
- FDA product code
- BTL — Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K123957
- Affected lot / code info
- SN RF70121
Why it was recalled
Two devices were labeled with the same serial number
Root cause (FDA determination)
Process control
Action the firm took
The firm notified the consignee by email on 07/15/2020 and requested the return of the units.
Recalling firm
- Firm
- Smiths Medical ASD Inc.
- Address
- 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690
Distribution
- Distribution pattern
- UK
Timeline
- Recall initiated
- 2021-07-15
- Terminated
- 2023-08-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #189265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.