Recall Z-2973-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-2973-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-31

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD Inc., initiated 2024-05-31. It names one FDA 510(k) clearance: K123957. Product: Pneupac paraPAC plus 300 ventilator kit, REF P300NXX. 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-05-31
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K123957 — PNEUPAC PARAPAC PLUSSmiths Medical International , Ltd.·cleared 2013-09-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.