CLASS II Device recall · Reported 27 Oct 2021 · FDA Enforcement Report
medfusion Stopcock, 1-way and 4-way recalled by Smiths Medical ASD
Smiths Medical ASD is recalling medfusion Stopcock, 1-way and 4-way. The recall was initiated on 10 May 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0155-2022
- FDA event ID
- 88725
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2018
- FDA classified
- 20 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 10 May 2018 | Recall initiated by company | |
| 20 Oct 2021 | Classified by FDA | +1259 days |
| 27 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product has a lack of sterility assurance
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.
Questions about this recall
Why was it recalled?
Product has a lack of sterility assurance
Which lots are affected?
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
Where was it sold?
International Distribution to countries of: Armenia, Austria, Germany, Great Britain, Hungary, Italy, New Zealand, Poland, Slovenia, Spain, Sweden, and Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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