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 |
|---|---|
DYNDA1224B | BREAST BIOPSY KIT |
DYNDH1121C | U/S CORE BIOPSY KIT |
DYNDH1124 | BIOPSY PACK |
DYNDH1147A | REVAMP BIOPSY TRAY |
DYNDH1266 | BREAST BIOPSY TRAY |
DYNDH1345A | BREAST BIOPSY TRAY |
DYNDH1496A | ULTRASOUND BREAST BIOPSY |
DYNDH1534 | BASIC BIOPSY TRAY |
DYNDH1542B | ULTRASOUND BIOPSY |
DYNDH1670 | CABARRUS BIOPSY TRAY |
DYNDH1677 | BREAST BIOPSY TRAY |
DYNDH1748 | NORTH PARK BIOPSY TRAY |
DYNDH1750 | SOFT TISSUE BIOPSY |
DYNDH1750A | SOFT TISSUE BIOPSY |
DYNDH1778 | UL BIOPSY TRAY |
DYNDH1822 | BREAST BIOPSY KIT |
DYNDH1828 | ULTRASOUND BIOPSY |
DYNJ0747885G | BIOPSY PACK-LF |
DYNJ34637G | BIOPSY TRAY |
DYNJ38616A | IGT BIOPSY PACK-LF |
- Amount recalled
- 47185 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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