Z-0155-2022Class II

medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d...

Name: Z-0155-2022 medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d...
Creator: Smiths Medical ASD Inc.
Published: 2018-05-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-05-10 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2018-05-10. FDA classified it as Class II and gives the reason as "Product has a lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0155-2022
Classification: Class II
Status: Terminated
Initiated: 2018-05-10
Posted: 2021-10-20
Terminated: 2023-09-15
Recalling firm: Abbott Medical
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
Product code: FMG Stopcock, I.V. Set
Reason for recall: Product has a lack of sterility assurance
Root cause tag: packaging
FDA 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 [email protected]. 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: [email protected].
Quantity in commerce: 933,518 units
Distribution: International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0155-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0155-2022	Class II	Terminated	Voluntary: Firm initiated	2021-10-27	2021-10-20

Product code FMG

K141254Class IIElcam Stopcocks and ManifoldsElcam Medical Acal / cleared 2014-07-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)