Class II — Potential Health Hazard

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

medfusion Stopcock Recalled by Smiths Medical ASD Inc. Due to Product has a lack of sterility assurance

Date: May 10, 2018
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

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g. 089-101E h. 888-101NE i. 081-102GEE j. 888-101BE k. 888-101GE l. 888-101GEE m. 081-101RE n. 081-102GE o. 081-102BE p. 888-101RE

Quantity: 933,518 units

Why Was This Recalled?

Product has a lack of sterility assurance

Where Was This Sold?

International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.

About Smiths Medical ASD Inc.

Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.

Related Recalls

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