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 |
|---|---|
ART920 | ARTERIAL LINE START KIT |
BSIPIV1005 | ULTRASOUND GUIDED PIV KIT |
BSIPIV1006 | ULTRASOUND GUIDED IV START KIT W/SHIELD |
BSIPIV1010 | PIV BSI KIT |
BSIPIV1011 | ULTRASOUND GUIDED PIV BUNDLE W/CHG DRSG |
CVI3805 | PICC INSERTION TRAY |
CVI4450B | PEDIATRIC PICC INSERTION TRAY |
DT19810 | CENTRAL LINE INSERTION TRAY |
DYNDA2509A | NEONATAL PICC INSERTION TRAY |
DYNDV2536 | USG PIV KIT |
DYNDV2547 | ULTRASOUND GUIDED IV START KIT |
DYNDV2567 | USG PIV KIT |
DYNJ68937A | POLY MIDLINE KIT 4F SL |
DYNJ70141MB | PICC KIT 4F SL PL MAX BARRIER |
DYNJ70152MB | PICC KIT 5F DL PL MB |
DYNJ80141MB | MIDLINE KIT 4F SL PL MAX BARR |
DYNJ80152MB | MIDLINE KIT 5F DL PL MAX BARR |
IVS3420B | ULTRASOUND GUIDED PIV KIT |
IVS3635C | ULTRASOUND GUIDED PIV INSERTION KIT |
IVS3770 | FLOOR ULTRASOUND GUIDED IV SECUREMENT |
- Amount recalled
- 70648 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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