Reported Oct 27, 2021 · Terminated
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e.…
Smiths Medical ASD Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
16 of 16 products
| # | Product as published |
|---|---|
| 1 | 081-101BE |
| 2 | 081-101GE |
| 3 | 081-101GEE |
| 4 | 081-101NE |
| 5 | 081-102NE |
| 6 | 081-102RE |
| 7 | 089-101E |
| 8 | 888-101NE |
| 9 | 081-102GEE |
| 10 | 888-101BE |
| 11 | 888-101GE |
| 12 | 888-101GEE |
| 13 | 081-101RE |
| 14 | 081-102GE |
| 15 | 081-102BE |
| 16 | 888-101RE |
- Lot codes and dates
- a. 081-101BE
- Serial Numbers
157034090115703444011570344402 b. 081-101GE
- Serial Numbers1570343301 c. 081-101GEE
- Serial Numbers
14702937011570343401 d. 081-101NE
- Serial Numbers
157032380115703410011570342701157034410116606881011670354301 e. 081-102NE
- Serial Numbers1660636701 f. 081-102RE
- Serial Numbers1660636601 g. 089-101E
- Serial Numbers
1570316801157034260115703446011660670001167034780116703552011670359701 h. 888-101NE
- Serial Numbers1570343001 i. 081-102GEE
- Serial Numbers1660636901 j. 888-101BE
- Serial Numbers
15703192011570343101157034420116703481011670348102 k. 888-101GE
- Serial Numbers
15703432011660688201 l. 888-101GEE
- Serial Numbers
14703123011570343501 m. 081-101RE
- Serial Numbers1570342901 n. 081-102GE
- Serial Numbers1660637101 o. 081-102BE
- Serial Numbers
15703169011660637501 p. 888-101RE
- Serial Numbers
15703443011670356201
- Amount recalled
- 933,518 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Product has a lack of sterility assurance
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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