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
19 of 19 products
| Model / number | Product as published |
|---|---|
CDS840214Q | FETAL SURGERY CDS-LF |
DYNDA2418 | MINOR PROCEDURE TRAY |
DYNJ0365463J | CLOSUREFAST PROCEDURE PACK-LF |
DYNJ24459P | BARIATRIC PACK |
DYNJ40629B | ABLATION PACK |
DYNJ44210B | ENDOLUMINAL ACCESSORY PACK |
DYNJ47716C | IR THYROID PACK (THLUF)642-LF |
DYNJ48520 | EVLT SURGICAL PACK |
DYNJ53059A | MAXIMAL BARRIER BEDSIDE PACK |
DYNJ59813 | LAPAROSCOPY PACK |
DYNJ61747C | PORT PACK |
DYNJ68027A | RR-BRACHY PACK |
DYNJ81410B | AV FISTULA PACK |
DYNJ82517 | ECMO PACK-LF |
DYNJ83966 | SYNERGY PROCEDURE PACK |
DYNJ906915 | MINOR |
DYNJ908046C | PROCEDURE PACK DR BILIMORI |
PHS751646C | ULTRASOUND PACK-LF |
PHS751646D | ULTRASOUND PACK-LF |
- Amount recalled
- 770147 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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