Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CADD Administration Sets with Flow Stop Recalled by Smiths Medical ASD, Inc. Due to Smiths Medical became aware that under delivery of...

Date: April 22, 2016
Company: Smiths Medical ASD, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD, Inc. directly.

Affected Products

CADD Administration Sets with Flow Stop, Product Reorder No: 21-7321-01, 21-7321-24, 21-7322-01, 21-7322-24, 21-7323-24, 21-7324-01, 21-7324-24, 21-7333-24, 21-7336-01, 21-7336-24, 21-7339-01, 21-7339-24, 21-7359-01, 21-7359-24, 21-7383-01, 21-7383-24, 21-7390-01, 21-7390-24, 21-7391-01, 21-7391-24, 21-7394-01, 21-7394-24, 21-7395-24. The CADD Medication Cassette Reservoirs with Flow Stop are a modification to the current CADD Medication Cassette Reservoirs. The reservoirs will incorporate a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the reservoirs are accidentally placed onto the pump incorrectly or become detached from the pump. The Flow Stop will be located on the reservoir housing, which is attached to the pump. The reservoir will be provided to the user in an open state. Before the reservoir can be attached to the pump, the blue "CLIP" must be removed to activate the Flow Stop. However, after attaching the reservoir to the pump, the user can still remove the reservoir from the pump and prime it by holding the Flow Stop in the open position.

Quantity: 13,696,830 units

Why Was This Recalled?

Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.

Where Was This Sold?

This product was distributed to 3 states: DE, IN, DC

Affected (3 states)Not affected

About Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc. has 114 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report