Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

FDA device recall Z-2973-2024 · posted 2024-09-11 · Open, Classified

Recall details

Recalling firm

Smiths Medical ASD Inc.

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BTL

Quantity affected

2198 units

Distribution

Worldwide

Date initiated

2024-05-31

Date posted

2024-09-11

Location

Minneapolis, MN

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