Smiths Medical ASD Inc.: 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

Recall number

Z-0155-2022

Recalling firm

Smiths Medical ASD Inc.

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

Status

Terminated

Initiated

2018-05-10

Posted

not on file

Terminated

2023-09-15

Reason

Product has a lack of sterility assurance

Root cause

Package design/selection

Action

The firm, Smiths Medical, notified their consignees of the recall by issuing an "URGENT MEDICAL DEVICE FIELD SAFETY NOTICE" dated 3/2018 on 05/10/2018. The notice described the product, problem and actions to be taken. The consignees/customers were instructed to do the following: PLEASE TAKE THE FOLLOWING ACTIONS TO HELP US PROPERLY EXECUTE THIS FIELD SAFETY CORRECTIVE ACTION: 1. Identify any affected Infusion Stopcocks in your possession 2. Determine the number of affected products in your possession and complete the Field Safety Notice (FSN) Response Form attached to this letter within 10 days of receipt; return it to smithsmedicalrecall@stericycle.com. The completed Response Form must be returned even if you do not have any of the affected Infusion Stopcocks in your possession. 3. All affected products must be returned to Stericycle for processing. If the completed Response Form indicates that you have product to return. 4. When you receive the pre-paid shipping labels, package the affected products by lot number. Include a copy of the completed Response Form inside EACH BOX of returned products. 5. FOR DISTRIBUTORS ONLY: If you have distributed any of the affected products to your customers, please immediately notify your customers of this Field Safety Corrective Action and retrieve all affected products. If you have any questions regarding this notification, contact Stericycle via email at the following address: smithsmedicalrecall@stericycle.com.

Quantity

933,518 units

Distribution

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

Lot, serial or model codes

a. 081-101BE, Serial Numbers: 1570340901, 1570344401, 1570344402  b. 081-101GE, Serial Numbers: 1570343301  c. 081-101GEE, Serial Numbers: 1470293701, 1570343401  d. 081-101NE, Serial Numbers: 1570323801, 1570341001, 1570342701, 1570344101, 1660688101, 1670354301  e. 081-102NE, Serial Numbers: 1660636701  f. 081-102RE, Serial Numbers: 1660636601  g. 089-101E, Serial Numbers: 1570316801, 1570342601, 1570344601, 1660670001, 1670347801, 1670355201, 1670359701  h. 888-101NE, Serial Numbers: 1570343001  i. 081-102GEE, Serial Numbers: 1660636901  j. 888-101BE, Serial Numbers: 1570319201, 1570343101, 1570344201, 1670348101, 1670348102  k. 888-101GE, Serial Numbers: 1570343201, 1660688201  l. 888-101GEE, Serial Numbers: 1470312301, 1570343501  m. 081-101RE, Serial Numbers: 1570342901  n. 081-102GE, Serial Numbers: 1660637101  o. 081-102BE, Serial Numbers: 1570316901, 1660637501  p. 888-101RE, Serial Numbers: 1570344301, 1670356201

510(k) numbers

["K141254"]

PMA numbers

not on file

Product code

FMG

Firm FEI

3012307300

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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