—#209122

Product

Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

FDA product code: BTL — Ventilator, Emergency, Powered (Resuscitator)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K123957
Affected lot / code info: All Serial Numbers.

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2024-05-31
Posted by FDA: 2024-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209122. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.