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 |
|---|---|
| — | CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C |
| — | CRMC TUNNEL CATH TRAY-LF, Model Numbers: DYNJ61118C, DYNJ61118F |
DYNJ41649G | CUSTOM ANGIO TRAY |
ECVC2595 | CUSTOM DUAL LUMEN 8.5 FRENCH CVC KIT |
| — | CV MINOR CDS, Model Numbers: CDS984100U, CDS984100V |
ECVC2225 | CVC 16CM BUNDLE |
ECVC7265A | CVC 3L 7F 20CM VANTEX |
ECVC3235 | CVC BUNDLE |
ECVC2335 | CVC BUNDLE 16CM |
ECVC5120B | CVC BUNDLE 20CM 3L |
ECVC5095B | CVC BUNDLE 4L 20CM |
| — | CVC BUNDLE 7FR, 3L, 20CM, Model Numbers: ECVC6075, ECVC6460 |
ECVC2240A | CVC BUNDLE KIT 16CM |
ECVC2001 | CVC BUNDLE KIT 20CM |
ECVC7205A | CVC BUNDLE KIT 7F 3L 16CM |
ECVC7200 | CVC BUNDLE KIT 7F 3L 20CM MULTIMED PI |
ECVC2205 | CVC BUNDLE KIT OR |
ECVC1970A | CVC BUNDLE KIT STANDARD |
ECVC5540A | CVC BUNDLE TRIPLE LUMEN 16CM |
ECVC6120 | CVC BUNDLE VANTEX 7FR, 20CM, 3L |
- Amount recalled
- 76,870 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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