Reported Apr 28, 2021 · Terminated
Manifold rotator (Component)
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?
Manifold rotator (Component)
4 of 4 products
| Model / number | Product as published |
|---|---|
MX1232MR | 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE |
MX1233MR | 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE |
MX1322MR | 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE |
MX1333MR. | 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Stopcocks and manifolds are used to control the direction of IV fluid flow. component of extravascular blood-pressure Transducer. |
- Lot codes and dates
- a. Model Number MX1232MR
- Lot Numbers4027757 b. Model Number MX1233MR
- Lot Numbers4076456 c. Model Number MX1322MR
- Lot Numbers
39923634011839 d. Model Number MX1333MR
- Lot Numbers4016439
- Amount recalled
- 1380 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
This product could cause temporary or reversible health problems — stop using it.
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