Recall Z-0163-2022— Smiths Medical ASD Inc.

Name: FDA recall Z-0163-2022
Creator: U.S. Food and Drug Administration
Published: 2021-07-15

Class III · Terminated

Class III FDA medical device recall by Smiths Medical ASD Inc., initiated 2021-07-15, terminated 2023-08-11. It names one FDA 510(k) clearance: K123957. Product: Pneupac paraPac plus 300 ventilator kit, REF P300NGB. Reason: Two devices were labeled with the same serial number.

Recalling firm: Smiths Medical ASD Inc.
Classification: Class III
Status: Terminated
Initiated: 2021-07-15
Terminated: 2023-08-11
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 P300NGB

Reason for recall

Two devices were labeled with the same serial number

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