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 |
|---|---|
DYNJ905151A | ANGIO |
DYNJ58346A | ANGIO/VENO PACK |
DYNJ57442C | ANGIOGRAPHIC PACK, , DYNJ64081A |
DYNJ65963 | ANGIOGRAPHY PACK |
DYNJ64655 | ANGIOPLASTY PACK-LF |
SPEC0232 | ARTHROGRAM TRAY |
DYNJ62591A | BASIC CATH/ANGIO |
DYNJ39752A | BASIC PACK |
DYNJ53064B | C.I.C.N. ANGIO PACK |
DYNJ64050 | CATH ANGIO PACK |
DYKMBNDL148 | DBD-KIT NEURO CAROTID SETUP |
DYNJ0878178I | DBS PACK-LF |
DYNJ57760A | GENERAL ANGIO PACK |
DYNJ57032C | GHIASSI NEURO ANGIO PACK-LF |
DYNJ39198L | IR NEURO PACK, , DYNJ39198N |
DYNJ906086A | KIT OR AORTOGRM ANGIOPLAST PHT |
DYNJ908260 | MAIN BASIC NEURO |
DYNJ66790 | NEURO ACCESSORY PACK, , DYNJ66790A, DYNJ66790B |
DYNJ69129 | NEURO CATH PACK, , DYNJ83090 |
DYNJ35066I | NEURO IR PACK, , DYNJ35066J, DYNJ60701A, DYNJ60701B, DYNJ60701C |
- Amount recalled
- 15,945 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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