Reported Jul 26, 2023 · Ongoing
Medline Probe Cover Kits containing sterile 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?
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following
26 of 26 products
| Model / number | Product as published |
|---|---|
ECVC1320 | VANTEX CVC BNDL, 3L 7F 16CM W MICROCLAVE |
ECVC1345A | CENTRAL VENOUS CATH INSERTION BUNDLE PI |
ECVC1490A | TRIPLE LUMEN CVC INSERTION TRAY |
ECVC1495A | TRIPLE LUMEN CVC INSERTION TRAY |
ECVC1725 | CENTRAL VENOUS CATHETER BNDLE KIT |
ECVC1915 | INTRODUCER/INTROFLEX BUNDLE KIT (P/S) |
ECVC1970B | 20CM 7F 3L CVC MAX BARRIER INSERTION |
ECVC2001 | CVC BUNDLE KIT 20CM |
ECVC2205A | 16CM 7F 3L CVC MAX BARRIER INSERTION |
ECVC2240A | CVC BUNDLE KIT 16CM |
ECVC2320 | FIRST HEALTH 16CM QUAD LUMEN KIT |
ECVC2440B | 7 FR 20CM CVC TRIPLE LUMEN BUNDLE |
ECVC2555 | 16CM TRIPLE LUMEN 7FR INSERT BUNDLE |
ECVC2560 | 20CM TRIPLE LUMEN 7FR INSERT BUNDLE |
ECVC2720 | FIRST HEALTH 20CM QUAD LUMEN TRAY |
ECVC2745 | CENTRAL LINE BUNDLE W/7F, 16CM, 3L |
ECVC2750 | CENTRAL LINE BUNDLE W/7F, 20CM, 3L |
ECVC2770 | 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT |
ECVC2895 | CVC INSERT BUNDLE 16CM TRIPLE LUMEN |
ECVC2930 | SHEATH INTRODUCER BUNDLE |
- Amount recalled
- 10080 units
This recall covers 53 products
The agency filed one notice per product. You are reading one of them; the other 52 are below.
40 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
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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