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 |
|---|---|
CDS840451L | OPEN HEART CDS-LF |
DYNJ908179 | OPEN HEART LINE SET UP, , DYNJ908179A |
DYNJ43741B | OPEN HEART PACK, , DYNJ66216, DYNJ66216A, DYNJ66216B, DYNJ66216C |
DYNJ53984G | OPEN HEART PACK A B |
DYNJ0283397T | OPEN HEART PACK A & B, , DYNJ0283397U, DYNJ53984F, DYNJ53984G |
DYNJ0371669N | OPEN HEART PACK-LF |
DYNJ22232W | OPEN HEART PACK-RF-LF |
DYNJ901075O | OPEN HEART PART 2, , DYNJ901075P |
DYNJ901821A | OPEN HEART PROCEDURE |
DYNJ63153B | OPEN HEART TAVR CONVERSION PK |
DYNJ63099F | OPEN HEART TAVR PACK |
DYNJ907858A | OPEN VASCULAR UE |
DYNJ62451 | OPEN VASCULAR UE PACK |
DYNJ906019B | OR ENDOVASCULAR, , DYNJ906019C |
DYNJ81295 | OR INTERVENTIONAL PACK |
DYNJ63069A | PACER SET UP PACK |
DYNJ60115B | PACK AV FISTULA |
NG340C | PACK MINOR VASCULAR |
DYNJ905692D | PACK VASCULAR BYPASS |
DYNJ54750G | PEDI EP PACK |
- Amount recalled
- 43,149 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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