Z-2974-2024Class I

Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX

Name: Z-2974-2024 Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Creator: Smiths Medical ASD Inc.
Published: 2024-05-31
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-05-31 / Open, Classified

FDA source

Smiths Medical ASD Inc. began a recall of Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX on 2024-05-31. FDA classified it as Class I and gives the reason as "There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2974-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-05-31
Posted: 2024-09-11
Recalling firm: Abbott Medical
Product: Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
Reason for recall: There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
FDA root cause: Under Investigation by firm
Action: Smiths Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 05/31/2024 by letter delivered via traceable means. The notice explained the issue, potential risk, and requested the following: "Customer Required Actions: 1. Identify all affected paraPac plus serial numbers in your possession. 2. Perform an inspection to determine if your devices are affected per the instructions below: a. Rotate the tidal volume knob to the lowest position of the control and evaluate whether or not the knob stays in position as set or if it moves to a higher position. b. Repeat this step, rotate tidal volume knob to the highest position of the control and evaluate whether the knob stays in position as set or if it moves to a lower position. c. If the knob stays in the position as set when tested, then your product is not affected, and you can continue use of the device as normal. Complete the attached Response Form confirming that you have no affected product. d. If the knob moves or changes position from the set position, then your product is affected, and it will need to be removed from use and repaired. Do not attempt to use or repair the affected product. Report the event to Global Complaint Management at [email protected]. Complete the attached Response Form identifying the number of affected products in your possession. 3. Share this recall notification with all potential users of the devices to ensure they are aware of this recall and proposed mitigations. 4. Return the attached Customer Response Form as noted above to [email protected] within ten days of receipt to acknowledge your understanding of this notification. 5. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]." Questions: https://icumed.custhelp.com/app/market- action; Technical
Quantity in commerce: 10,240 units
Distribution: Worldwide
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2974-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2973-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11
Z-2974-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-11

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)