Recall Z-3090-2024— Smiths Medical ASD Inc.

Name: FDA recall Z-3090-2024
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: paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N. Reason: Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function..

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

Reason for recall

Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.

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