Recall Z-0148-2022— Smiths Medical ASD Inc.

Name: FDA recall Z-0148-2022
Creator: U.S. Food and Drug Administration
Published: 2020-07-14

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2020-07-14, terminated 2023-08-04. It names one FDA 510(k) clearance: K031361. Product: CADD Administration Sets, Model #21-7346-24. Reason: Product may have been manufactured with an air filter assembled in an incorrect orientation..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-07-14
Terminated: 2023-08-04
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K031361 — CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOPDeltec, Inc.·cleared 2003-05-23

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

CADD Administration Sets, Model #21-7346-24

Reason for recall

Product may have been manufactured with an air filter assembled in an incorrect orientation.

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