Z-0163-2022Class III

Pneupac paraPac plus 300 ventilator kit, REF P300NGB

Name: Z-0163-2022 Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Creator: Smiths Medical ASD Inc.
Published: 2021-07-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-07-15 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Pneupac paraPac plus 300 ventilator kit, REF P300NGB on 2021-07-15. FDA classified it as Class III and gives the reason as "Two devices were labeled with the same serial number". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0163-2022
Classification: Class III
Status: Terminated
Initiated: 2021-07-15
Posted: 2021-10-22
Terminated: 2023-08-11
Recalling firm: Abbott Medical
Product: Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
Reason for recall: Two devices were labeled with the same serial number
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified the consignee by email on 07/15/2020 and requested the return of the units.
Quantity in commerce: 2 units
Distribution: UK
Product codes and lots: SN RF70121

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0163-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0163-2022	Class III	Terminated	Voluntary: Firm initiated	2021-11-03	2021-10-22

Product code BTL

K123957Class IIPneupac Parapac PlusSmiths Medical International , Ltd. / cleared 2013-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)