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 |
|---|---|
DYNJ65711 | A V FISTULA |
DYNJ64141A | ACCESS CATHETER |
DYNJ40682B | ACCESS PICC PACK |
DYNDA2482 | ADULT EPIV INSERTION TRAY |
DYNJ67534 | AFCH CVC INSERTION |
DYNJ81725 | ANGIOGRAM-DECH-LF |
ART900 | ART LINE KIT ICH OR |
DYNJ49235D | ARTERIAL LINE PACK |
DYNJ53095A | ARTERIOGRAM PACK, , DYNJ55169G |
DYNJ64143A | AV FISTULA, , DYNJ905219A, DYNJ906341C, DYNJ906945 |
DYNJ52093I | AV FISTULA PACK, , DYNJ62733, DYNJ66916, DYNJ67178 |
DYNJ48428C | AV FISTULA PACK-LF, , DYNJ64499A, DYNJ69167 |
DYNJ0781844W | AV SHUNT PACK-LF |
DYNJ901145F | BARIATRIC KIT |
DYNJ69426 | BASIC VEIN PACK |
DYNJ69796 | BCH VEIN ABLATION |
DYNJ60329A | CATH LAB-VEIN PROCEDURES |
DYNJ22338K | CENTRAL LINE BUNDLE PACK-LF |
DYNJ52894A | CENTRAL LINE INSERTION KIT |
CVI4805 | CENTRAL LINE INSERTION PACK |
- Amount recalled
- 146,157 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.
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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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