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 |
|---|---|
ARTNC115 | NO-CATH RADIAL ARTERIAL PREMIU |
CDS980752I | MAJOR VASCULAR |
CDS982858F | PICC LINE DOUBLE LUMEN CDS |
CDS982859F | PICC LINE TRIPLE LUMEN CDS |
CDS983082J | CHP TRANSPLANT CDS |
CDS983704I | CLOSURE CDS |
CVI4340 | MIDLINE INSERTION TRAY |
CVI4765 | PORT INSERTION PACK |
DYND2673B | MAX BARRIER KIT |
DYNDA1468C | POWERGLIDE PLACEMENT KIT |
DYNDA2011B | DEPIPPO PACK |
DYNDA2076 | VEIN PROCEDURE KIT |
DYNDA2148A | SCLEROTHERAPY KIT |
DYNDA2365B | IR SONO PACK |
DYNDC2099 | ULTRASOUND BASIC KIT |
DYNDC2399A | PIV WITH ULTRASOUND KIT |
DYNDH1165A | PARA THORACENTESIS TRAY |
DYNDH1204 | ULTRASOUND TRAY |
DYNDH1292 | PARA/THORACENTESIS TRAY |
DYNDH1319 | ULTRASOUND GUIDE BREAST BIOPSY |
- 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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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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