Reported Aug 9, 2023 · Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz 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

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following

17 of 17 products

Products covered by this recall
Model / number	Product as published
`DYNJ54287A`	CAROTID
`DYNJ66190`	CAROTID PACK
`DYNJ905622C`	CAROTID SUPPLY
`DYNJ901745J`	CAROTID-LF
`DYNJ63347A`	CENTRAL LINE INSERTION
`CDS983069G`	CHP COCHLEAR SUPPLEMENT CDS
`CDS983069I`	DBD-CHP COCHLEAR SUPPLEMENT CDS
`DYNJ47716B`	DBD-IR THYROID PACK THLUF642-LF
`SYNJ910018A`	ENT FREE FLAP
`DYNJ67954A`	ENT FREE FLAP PACK
`DYNJ65706`	FEM CAROTID PACK
`DYNJ905340A`	FLAP ENT FREE
`DYNJ20495J`	FREE FLAP PACK-LF
`DYNJ30245`	PACK HEAD NECK
`DYNJ43861D`	SVMMC CAROTID PACK
`DYNJ63634A`	TAVR FAIRFAX
`DYNJ44410F`	VNUS TRAY

The agency filed one notice per product. You are reading one of them; the other 49 are below.

37 more are in the archive.

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

This product could cause temporary or reversible health problems — stop using it.

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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80 in total.