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
Is this the product you have?
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following
26 of 26 products
| Model / number | Product as published |
|---|---|
DYNJ44847I | AAA PACK |
DYNJ82578 | ABDOMINAL VASCULAR PACK |
| — | ABDOMINAL VASCULAR-LF, Model Numbers: DYNJ905291B, DYNJ905291C |
DYNJ61957A | ABLATION PACK |
DYNJ36600F | ACCESSORY OPEN HEART PACK |
| — | ADULT CORONARY PACK, Model Numbers: DYNJV0275J, DYNJV0275K, DYNJV0275L, DYNJV0275M |
DYNJ69682 | AFIB PACK |
CDS840493F | ALT MINOR VASCULAR CDS |
DYNJ24272C | ANGIO-VASCULAR |
DYNJ905290D | ARM VASCULAR-LF |
DYNDC3038 | ARTERIAL/VENOUS ACCESS TRAY |
| — | ARTERIOGRAM PACK, Model Numbers: DYNJ81636, DYNJ81636A |
DYNJ83051 | ARTERIOGRAM PACK 2 |
DYNJ40728D | AUD MAJOR VASC PK-LF |
DYNJ40728A | AUD MAJOR VASCULAR-LF, , DYNJ40728B, DYNJ40728C |
DYNJ83462 | AV FIST PACK |
| — | AV FISTULA, Model Numbers: DYNJ64143B, DYNJ905219B, DYNJ905219C, DYNJ905219D; DYNJ905219F, DYNJ906341D, DYNJ906945A, DYNJ907975, DYNJ907975B, DYNJ908096 |
DYNJ82570 | AV FISTULA CAROTID PACK |
DYNJ52093J | AV FISTULA PACK, , DYNJ62218B, DYNJ66184A, DYNJ66184B, DYNJ67178A, DYNJ69443A, DYNJ69443B, DYNJ69443D, DYNJ69489A, DYNJ81033, DYNJ81605, DYNJ82477 |
DYNJ64499B | AV FISTULA PACK-LF, , DYNJ64499D, DYNJ69167A, DYNJ69167C |
- Amount recalled
- 46,124 kits
This recall covers 50 products
The agency filed one notice per product. You are reading one of them; the other 49 are below.
37 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
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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