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 |
|---|---|
00-400305R | ANGIOGRAPHY DRAPE PACK |
DYNJ0037936C | ANGIO HOLLAND PACK-LF |
DYNJ0037936D | ANGIO HOLLAND PACK-LF |
DYNJ0149444N | ANGIOGRAM |
DYNJ0198765G | DIALYSIS CATH INSERTION PK-LF |
DYNJ0275614F | PICC LINE PACK-LF |
DYNJ0290716M | ANGIOGRAPHY PACK-LF |
DYNJ0313233V | ANGIO CATH LAB PACK-LF |
DYNJ0313233W | ANGIO CATH LAB PACK-LF |
DYNJ0313233X | ANGIO CATH LAB PACK-LF |
DYNJ0407399P | ANGIO PACK-LF |
DYNJ0416535AA | SPECIAL PROCEDURE PACK-LF |
DYNJ0429121K | VISCERAL ANGIOGRAM PACK-LF |
DYNJ0429185L | CARDIAC EP PACK-LF |
DYNJ0458661C | SPECIAL PROCEDURE PACK-LF |
DYNJ0537652AG | LT HEART/ANGIOGRAPHY PACK-LF |
DYNJ0545064AA | CATH LAB ANGIO PACK-LF |
DYNJ0604508R | SPECIAL PROCEDURE PK-LF |
DYNJ0842644F | CARDIAC CATH PACK-LF |
DYNJ0843244K | PEDIATRIC CATH PACK-LF |
- Amount recalled
- 173449 units
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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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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