Reported Jul 26, 2023 · Ongoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model…
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 followinga) FETAL SURGERY CDS-LF, Model Number CDS840214P; b) ABLATION PACK, Model Number DYNJ82725
- Lot codes and dates
- all lots within expiry, distributed from Medline
- between December 2017 - May 2023
a) Model Number CDS840214PUDI/DI (EA) 10193489443196UDI/DI (CS) 40193489443197b) Model Number DYNJ82725UDI/DI (EA) 10195327207380UDI/DI (CS) 40195327207381
- Amount recalled
- 316 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.
Want the full recall guide?
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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