Recall Z-1767-2017— Smiths Medical ASD Inc.

Name: FDA recall Z-1767-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-17

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2017-03-17, terminated 2019-07-03. It names one FDA 510(k) clearance: K040636. Product: CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.. Reason: Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-17
Terminated: 2019-07-03
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K040636 — CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SETSmiths Medical MD, Inc.·cleared 2004-05-19

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 Set, 21-7339-24, Rx Only, Sterile EO.

Reason for recall

Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.

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