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
19 of 19 products
| Model / number | Product as published |
|---|---|
DYNJ83105 | CATH PACK |
DYNJ83251 | TESIO |
DYNJ83508 | ANGIOGRAPHY PACK-LF |
DYNJ83656 | OR ANGIOGRAM PACK-LF |
DYNJ83696 | FERRELL-DUCAN ANGIO |
DYNJ83746 | ANGIO KIT PACK |
DYNJ83815 | M&E ARTERIOGRAM PK |
DYNJ83918 | ANGIOGRAPHY CV RAD PACK |
DYNJ83936 | ANGIO PACK |
DYNJ84040 | ARTERIOGRAM - SUMMIT PACK |
DYNJ84190 | ANGIO PACK |
DYNJ902507C | ANGIO |
DYNJ902507D | ANGIO |
DYNJ905151B | ANGIO |
DYNJ906766B | PACK ANGIOPLASTY CV,8405 |
DYNJ908249A | (13) STC IVC FILTER/ANGIOGRAM |
DYNJ909267 | OR ANGIOGRAM |
DYNJVB1000 | RADIOLOGY PACK #108402-LF |
SYNJ10303C | HYBRID OR PACK |
- Amount recalled
- # included in 3,740,814 units 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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