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 |
|---|---|
DYNJ67517 | DR. ROSEN VEIN PACK |
DYNJ51416B | DR. VANBOSSE LOWER EXT PACK |
DYNJ42913 | DRAINAGE TRAY, , DYNJ42913A |
DYNJ61243 | ECMO PACK |
DYNJ66291 | EGG RETRIEVAL PACK, , DYNJ66291A |
DYNJ57449A | EH TAVR PACK |
DYNJ26940G | ELVS PACK-LF |
DYNJ60126 | ENDO AAA HYBRID CHRG |
DYNJ54265 | ENDOVASCULAR OR PACK |
DYNJ59085 | ENDOVASCULAR PACK |
DYNJ42831D | ENDOVASCULAR PACK-LF |
DYNJ53435C | ENDOVENOUS ABLATION PACK |
DYNJ48456B | ENDOVENOUS BASIC PACK |
DYNJ59168 | ENDOVENOUS CORE PACK |
DYNJ58228 | ENDOVENOUS PACK |
DYNJ62443 | ENS BIOPSIE THYROIDE-HEJ-LF |
DYNJ59392C | EP LAB |
DYNJ907013 | EP MERCY JANESVILLE |
DYNJ57594A | EP PACK |
DYNJ900005L | EVAR |
- Amount recalled
- 93,587 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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