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 |
|---|---|
DYNJ908249A | (13) STC IVC FILTER/ANGIOGRAM |
| — | 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A |
ECVC2205A | 16CM 7F 3L CVC MAX BARRIER INSERTION |
ECVC8095 | 16CM 7F CVC INSERTION TRAY |
ECVC5010A | 16CM CVC BUNDLE W/MICROPUNCTURE KIT |
ECVC6800A | 16CM CVC INSERTION KIT |
ECVC2555 | 16CM TRIPLE LUMEN 7FR INSERT BUNDLE |
ECVC4125 | 16CM TRIPLE LUMEN CVC INSERT BUNDLE |
ECVC5135B | 20CM 3L 7FR CVC INSERTION BUNDLE |
ECVC7325 | 20CM 3L CVC INSERTION TRAY |
ECVC1970B | 20CM 7F 3L CVC MAX BARRIER INSERTION |
ECVC4335 | 20CM 7F CVC INSERTION TRAY |
ECVC7160 | 20CM CVC TRIPLE LUMEN SAFETY BUNDLE |
ECVC2560 | 20CM TRIPLE LUMEN 7FR INSERT BUNDLE |
ECVC3505 | 20CM, 3L INSERT BUNDLE-CINCINNATI VA |
ECVC7075 | 2L 7FR 20CM CVC INSERTION TRAY |
ECVC8055 | 2L 8.5FR 16CM CVC INSERTION KIT |
ECVC8165 | 3L 7FR 16 CM CVC INSERTION TRAY |
| — | 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US |
ECVC7600 | 3L 7FR 20CM CVC INSERTION BUNDLE |
- Amount recalled
- 97,677 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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