FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
- Recall number
- Z-2974-2024
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
- Status
- Open, Classified
- Initiated
- 2024-05-31
- Posted
- 2024-09-11
- Terminated
- not on file
- Reason
- 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.
- 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 globalcomplaints@icumed.com. 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 smithsmedical3920@sedgwick.com 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 smithsmedical3920@sedgwick.com." Questions: https://icumed.custhelp.com/app/market- action; Technical
- Quantity
- 10,240 units
- Distribution
- Worldwide
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K123957"]
- PMA numbers
- not on file
- Product code
- BTL
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28