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 |
|---|---|
DYNJ40629B | ABLATION PACK |
DYNJ81410B | AV FISTULA PACK |
DYNJ901145G | BARIATRIC KIT |
DYNJC9299M | BARIATRIC LAPAROSCOPY R-Y PACK, , DYNJC9299O |
DYNJ24459P | BARIATRIC PACK |
DYNJ36242 | CENTRAL CATHETER INSERTION PK |
DYNJ60667C | CYSTO PACK, , DYNJ60667D, DYNJ60667F, DYNJ83942 |
DYNJ905761A | DBD-FETOSCOPIC |
DYNJ68447B | DBD-FREE FLAP NO DRAPE PACK NTX |
DYNJ69204A | DBD-HILLCREST PCNL PACK |
DYNJ901296B | DIEP |
DYNJ66867A | DIEP FLAP |
DYNJ0426069N | DONOR FREE FLAP PACK-LF |
DYNJ82517 | ECMO PACK |
DYNJ44210B | ENDOLUMINAL ACCESSORY PACK |
DYNJ63343G | ENDOVASCULAR |
DYNJ48520 | EVLT SURGICAL PACK |
CDS840214Q | FETAL SURGERY CDS-LF |
DYNJ907076A | FLAP, , DYNJ907076B, DYNJ907076C |
DYNJ58575B | FLAP HARVEST PACK |
- Amount recalled
- 16,143 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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