Recall Z-2974-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-2974-2024
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 310 ventilator kit with PEEP and CPAP, REF P310NXX. 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 310 ventilator kit with PEEP and CPAP, REF P310NXX

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.