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 |
|---|---|
DYNJ22350K | VASCULAR PACK, , DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYNJ53438A, DYNJ53610C, DYNJ53995G, DYNJ56791A, DYNJ56791B, DYNJ57490A, DYNJ58608, DYNJ58681A, DYNJ58681B, DYNJ58710, DYNJ61325A, DYNJ61325B, DYNJ61528, DYNJ62399A, DYNJ65160, DYNJ66356, DYNJ66356A, DYNJ66356B, DYNJ66356C, DYNJ66356D, DYNJ66577, DYNJ68492A, DYNJ68492B, DYNJ68492C, DYNJ68492D, DYNJ68863, DYNJ68863A, DYNJ68880, DYNJ80599, DYNJ81626, DYNJ82016, DYNJ82104, DYNJ82144, DYNJ82769, DYNJ82769A, DYNJ83146 |
DYNJ59778A | VASCULAR PACK CHRG, , DYNJ59778B |
DYNJ59245 | VASCULAR PACK GWV, ; DYNJ59245A |
DYNJ39866B | VASCULAR PACK MH-LF, , DYNJ39866C |
DYNJ68404 | VASCULAR PACK SHD |
DYNJ0250564O | VASCULAR PACK-LF, , DYNJ0250564P, DYNJ0373040N, DYNJ0493141G, DYNJ0493141I, DYNJ0493141J, DYNJ0871182AC, DYNJ0901358I, DYNJ0901358J, DYNJ0901358K, DYNJ53475F, DYNJ53684A, PHS400047N, PHS400047O |
DYNJ906440A | VASCULAR STENT INOVA |
DYNJ56858 | VASCULAR TRAY |
DYNJ905079F | VASCULAR/OR ANGIO |
DYNJ900714B | VASCULAR-LF, , DYNJ900714C |
DYNJ52586B | VEIN ABLATION EXCISION ASC |
DYNJ52586 | VEIN ABLATION & EXCISION ASC, , DYNJ52586A, DYNJ52586B |
DYNJ69272A | VEIN ABLATION KIT |
DYNJ62889 | VEIN ABLATION PACK |
DYNJ64396 | VEIN ABLATION TRAY W/CHLOR |
DYNJ49874 | VEIN AND LASER PACK |
DYNJ52123 | VEIN CENTER PACK |
DYNJ68667 | VEIN CLINIC |
DYNJ35586G | VEIN CLOSURE PACK, , DYNJ39408F, DYNJ65189B |
DYNJ44737B | VEIN CLOSURE TRAY |
- Amount recalled
- 100,549 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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