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 |
|---|---|
ART1005 | FEMORAL ARTERIAL LINE BUNDLE |
ART1165 | 20GX6" FEMORAL ART LINE KIT |
ART240A | 3" RADIAL ARTERIAL LINE KIT |
ART245A | 6" FEMORAL ARTERIAL LINE KIT |
ART245B | 6" FEMORAL ARTERIAL LINE KIT |
ART255 | ARTERIAL LINE BUNDLE |
ART560 | ARTERIAL LINE BUNDLE |
ART690 | A LINE TRAY |
ART840 | ARTERIAL LINE TRAY |
ART960 | 18GX6" FEMORAL ART LINE KIT |
ART970 | 20Gx3" RADIAL ART LINE KIT |
BT235A | BIOPSY/ASPIRATION TRAY |
CHT1825 | PERCUTANEOUS CHEST TUBE KIT |
CVI3735 | PICC INSERTION KIT |
CVI4025A | PICC INSERTION BUNDLE |
CVI4180 | VASCULAR ACCESS INSERTION KIT |
CVI4265 | VASCULAR ACCESS INSERT KIT-PEDIATRICS |
CVI4430 | UNIVERSAL CVC ZONE DEFENSE BUNDLE |
CVI4450A | PEDIATRIC PICC INSERTION TRAY |
CVI4505 | CVC ACCESSORY BUNDLE |
- Amount recalled
- 39391 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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