Reported Jul 26, 2023 · Ongoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following
MEDLINE INDUSTRIES, LP - Northfield
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: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following
26 of 26 products
| Model / number | Product as published |
|---|---|
DYNJ55252C | ANGIOGRAPHY PACK |
DYNJ55455A | CATH LAB PACK |
DYNJ55680A | CATH LAB 2 |
DYNJ56038A | IR ANGIO TRAY |
DYNJ56547C | CATH PACK |
DYNJ57049G | HYBRID |
DYNJ57049I | HYBRID |
DYNJ57049J | HYBRID |
DYNJ57645C | PERCUTANEOUS ANGIO PACK-LF |
DYNJ57760C | GENERAL ANGIO PACK |
DYNJ57792C | ENSEMBLE ANGIOGRAPHIE-LF |
DYNJ58111D | ANGIO PACK |
DYNJ58111F | ANGIO PACK |
DYNJ58162 | PORT PACK |
DYNJ58178B | ENSEMBLE ANGIO CEREBRALE-LF |
DYNJ58510A | PERIPHERAL CATHETER #668236-V |
DYNJ59184B | OR ANGIO PACK |
DYNJ59307F | PORT A CATH PACK |
DYNJ59632D | CATH PACK |
DYNJ60112B | PACK PERCUTANEOUS ANGIO CHRG |
- Amount recalled
- 3,740,814 units in total
This recall covers 53 products
The agency filed one notice per product. You are reading one of them; the other 52 are below.
40 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
This product could cause temporary or reversible health problems — stop using it.
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