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 |
|---|---|
DYNJ53658B | ABLATION/DRAINAGE PACK |
DYNDH1534 | BASIC BIOPSY TRAY |
DYNDH1124 | BIOPSY PACK, , DYNJ50485 |
DYNJ0747885G | BIOPSY PACK-LF |
DYNJ59752A | BIOPSY RAD CT |
DYNDH1748 | BIOPSY TRAY, , DYNJ34637F, DYNJ34637G, DYNJ43076, DYNJ43076A, DYNJ62690 |
DYNJ42307A | BIOPSY WITH PROB COVER WRO-LF |
DYNDA1224B | BREAST BIOPSY KIT |
DYNDH1266 | BREAST BIOPSY TRAY, , DYNDH1302, DYNDH1345A, DYNDH1677 |
DYNDH1670 | CABARRUS BIOPSY TRAY |
DYNJ42752A | CORE BIOPSY PACK-LF |
P365500 | GENERAL BIOPSY PACK |
DYNJ38616A | IGT BIOPSY PACK-LF |
DYNJ63688I | IR BIOPSY PACK |
DYNJVB91015A | PROSTATE BIOPSY |
DYNJ56578 | PROSTATE BIOPSY PACK |
SPEC0168 | RENAL BIOPSY TRAY |
DYNDH1147A | REVAMP BIOPSY TRAY |
DYNDH1750 | SOFT TISSUE BIOPSY |
DYNDH1288 | THYROID BIOPSY TRAY |
- Amount recalled
- 43,613 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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