Reported Jan 24, 2024 · Ongoing
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
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 · 6250 Shier Rings Rd · Dublin, OH · 43016-1270
Is this the product you have?
- HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
- Lot codes and dates
- Lot Number4332915 4408772
- Amount recalled
- 31,685 total
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
This product could cause temporary or reversible health problems — stop using it.
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