RecallRadar

FDA Device recall Z-0163-2022

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

On 2021-11-03 the FDA classified a Class III recall of Pneupac paraPac plus 300 ventilator kit, REF P300NGB by Smiths Medical Asd, citing two devices were labeled with the same serial number.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0163-2022
ClassificationClass III
Statusterminated
Initiated2021-07-15
Published2021-11-03
Last updated2026-09-13 11:56 UTC
CompanySmiths Medical Asd
Distributionn/a

Product

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

Reason

Two devices were labeled with the same serial number

Identifiers

code_infoSN RF70121

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0163-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.