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 |
|---|---|
DYNJ54755B | PEDIATRIC CATH ANGIO PACK |
DYNJ40306A | PEDIATRIC MAX BARRIER KIT-LF |
DYNJ0774759P | PERC PACK-LF |
DYNJ902261D | PERCUTANEOUS VASCULAR CDS |
DYNJRA1747 | PERIPHERAL NERVE BLOCK KIT/P |
DYNJ44960D | PERIPHERAL PACK |
DYNDV2285 | PERIPHERAL ULTRASOUND CATHETER, , MNS9865 |
DYNJ904401B | PERIPHERAL VASCULAR GRAFT PACK |
DYNJ42262D | PERMACATH-LF |
DYNJ47502B | PHLEBECTOMY PACK |
DYNJ67414 | PHYSIATRY PACK |
PHS41739A | PICC INSERT KIT-LESS THAN 3 FR |
DYNJ60038 | PICC INSERTION PACK |
CDS982858F | PICC LINE DOUBLE LUMEN CDS |
DYNJ39885A | PICC LINE INSERTION |
DYNJ41873B | PICC LINE INSERTION WRO-LF |
DYNJ52688A | PICC LINE TRAY |
CDS982859F | PICC LINE TRIPLE LUMEN CDS |
DYNJ47717 | PICC LINEPACK (PCLUI)642-LF |
DYNJ55723A | PICC PACK, , DYNJ60990 |
- Amount recalled
- 233,638 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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