Recall Z-2589-2017— Smiths Medical ASD Inc.

Name: FDA recall Z-2589-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-15

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2017-05-15, terminated 2018-04-04. It names one FDA 510(k) clearance: K031361. Product: CADD¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set is designed for use with the CADD¿ Prizm pump to allow fluid deliver from an IV bag.. Reason: One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-05-15
Terminated: 2018-04-04
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¿ High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD¿ High-Volume Administration set is designed for use with the CADD¿ Prizm pump to allow fluid deliver from an IV bag.

Reason for recall

One lot of CADD¿ High Volume Administration sets, part number 21-7381-24, lot number 26X035, incorrectly contained the IFU insert for part number 21-7357-24.

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