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 |
|---|---|
ECVC4740 | 7F, 20CM TRIPLE LUMEN CVC BUNDLE |
DYNJ36212C | A V GRAFT |
DYNJ905651 | AAA, , DYNJ905651A, DYNJ905651B |
DYNJ44918C | AAA PACK |
DYNJ44847G | AAA PACK - TEAM 3 |
DYNJ62540 | ABLATION PACK, , DYNJ64068 |
DYNJ53658A | ABLATION/DRAINAGE PACK |
DYNDH1159A | ACCESS KIT |
DYNJ69017 | ACCESS PACK |
DYNJ901348D | ACCESSORY KIT |
DYNJV0275F | ADULT CORONARY PACK |
DYNJ38714B | ADULT CVC MAX BARRIER KIT-LF |
DYNJ63576 | ALL PURPOSE TRAY FOAKS, , DYNJ63576A |
DYNDH1649 | AMINO KIT |
DYNDH1420 | AMNIOCENTESIS TRAY |
DYNJ0370436Q | ANGIO STANDARD PACK-LF |
DYNJ23438J | ANGIO TRAY |
DYNJ47004B | ANGIOGRAM PACK |
DYNJ33638I | ANGIOGRAM TRAY |
DYNJ24272B | ANGIO-VASCULAR |
- Amount recalled
- 83,541 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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