Recall Z-0155-2022— Smiths Medical ASD Inc.

Name: FDA recall Z-0155-2022
Creator: U.S. Food and Drug Administration
Published: 2018-05-10

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2018-05-10, terminated 2023-09-15. It names one FDA 510(k) clearance: K141254. Product: 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. Reason: Product has a lack of sterility assurance.

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Terminated: 2023-09-15
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K141254 — ELCAM STOPCOCKS AND MANIFOLDSElcam Medical Acal·cleared 2014-07-30

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

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

Reason for recall

Product has a lack of sterility assurance

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