Reported Apr 28, 2021 · Terminated
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number…
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?
- HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
- Lot codes and dates
- a. Model Number MX496HP
- Lot Numbers
39524803974771 b. Model Number MX497HP
- Lot Numbers
39493913971003
- Amount recalled
- 8150 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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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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