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 |
|---|---|
DYNDA2482 | ADULT EPIV INSERTION TRAY |
ART920 | ARTERIAL LINE START KIT |
DT19810 | CENTRAL LINE INSERTION TRAY |
CVI4915 | ECMO INSERTION BUNDLE W/O CANNULA |
IVS3770 | FLOOR ULTRASOUND GUIDED IV SECUREMENT |
DYNDV2407A | IV SECUREMENT KIT |
MID0005 | MIDLINE BUNDLE 4FR SL |
CVI4340 | MIDLINE INSERTION TRAY |
MIDST04011 | MIDLINE KIT 4F SL MAX BARRIER STD |
MID0001 | MIDLINE KIT 4F SL MB |
DYNJ80141MB | MIDLINE KIT 4F SL PL MAX BARR, , MID0003 |
PICC0009A | MIDLINE KIT 4F SL PL MB |
DYNJ80152MB | MIDLINE KIT 5F DL PL MAX BARR |
DYNDA2509A | NEONATAL PICC INSERTION TRAY, , MNS8765 |
DYNDC2120B | NEONATAL PICC LINE INSERTION TRAY |
CVI3740A | NICU PICC TRAY |
IVS3990 | PED ULTRASOUND GUIDED PIV |
CVI4450B | PEDIATRIC PICC INSERTION TRAY |
DYNDV2285 | PERIPHERAL ULTRASOUND CATHETER INSERTION, , MNS9865 |
PICC0013 | PICC BUNDLE 5FR DL |
- Amount recalled
- 218,163 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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