FDA Device recall Z-0155-2022
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.…
- FDA Device
- Class II
- terminated
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II 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.… by Smiths Medical Asd, citing product has a lack of sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0155-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-10 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
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
Identifiers
| code_info | a. 081-101BE, Serial Numbers: 1570340901, 1570344401, 1570344402 b. 081-101GE, Serial Numbers: 1570343301 c. 08…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0155-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.