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 |
|---|---|
DYNJ65963A | ANGIOGRAPHY PACK |
PAIN1524B | ARTHOGRAM TRAY |
PAIN1524A | ARTHROGRAM TRAY |
DYNJ63149A | CARPAL TUNNEL KIT |
CDS981753L | CRANIOTOMY CDS |
CDS982889I | CRANIOTOMY CDS-1 |
DYNJ61749A | CRANIOTOMY PACK |
DYNDH1722 | DBD-JOINT INJECTION TRAY |
OST011E | ENS STERILE POUR IMPLANT-LF |
DYNJ909168 | FREE FLAP LOWER EXT-LF |
DYNJ909169 | FREE FLAP UPPER EXT-LF |
DYNJ56907D | HYBRID PACK |
DYNJ50712C | IR ARM PACK |
SPEC0204D | LOWER EXTREMITY BLOCK PACK-RX |
DYNJ69312 | MURRIETA PACK, , DYNJ69312A |
DYNJ53035B | OASC IVF PACK |
DYNJRA1619 | PERIPHERAL NERVE BLOCK KIT |
PHS392881009C | RO VASCULAR EXTREMITY PK-LF |
DYNJ906551A | SCO ARTHROSCOPY |
DYKS1241A | SHOULDER BLOCK KIT |
- Amount recalled
- 15,323 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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