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 |
|---|---|
00-401318M | ANGIOGRAPHY DRP PK PEDI CATH |
CDS984944C | ANGIOGRAPHY OR |
DYNJ0149444M | ANGIOGRAM |
DYNJ0160556D | EP LAB DEVICE PACK-LF |
DYNJ0201109AG | VASCULAR ANGIO PACK-LF |
DYNJ0373279M | ANGIO PACK-LF |
DYNJ0429121I | VISCERAL ANGIOGRAM PACK-LF |
DYNJ0806254D | IPMC ANGIOGRAPHY PACK-LF |
DYNJ0854485T | ANGIOGRAPHY PACK-LF |
DYNJ17624B | ANGIO DRAPE PACK |
DYNJ19939M | DEPAUL ANGIO PACK |
DYNJ24225K | EP ANGIOGRAPHY PACK |
DYNJ28067G | ANGIOGRAPHY DRAPE PACK-LF |
DYNJ33457C | DASHTI-YAO NEURO ANGIO-LF |
DYNJ33638K | ANGIOGRAM TRAY |
DYNJ34361 | ANGIO PACK |
DYNJ36049 | ANGIO/PICC PACK |
DYNJ37665B | IR MINOR ANGIO PACK |
DYNJ40632C | ANGIO LEFT HEART PACK |
DYNJ41553D | MV-IR ANGIO DRAPE PACK-LF |
- Amount recalled
- 55014 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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