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
15 of 15 products
| Model / number | Product as published |
|---|---|
CVI3755 | CENTRAL LINE INSERT KIT W/O CA |
DYNDC2582 | CENTRAL LINE KIT, , DYNDC2582A |
DYNJ47215D | CENTRAL LINE PACK-COMPANION |
DYNJ42902B | CENTRAL LINE TRAY |
CVI3780 | CENTRAL LINE UNIVERSAL INSERTION |
DYNJ83054A | CLOSURE PACK |
DYNJ47717A | DBD-PICC LINEPACK PCLUI642-LF |
P155508B | ER CENTRAL LINE KIT, , P155508C |
DYNJ63347 | HEMODIALYSIS CENTRAL LINE |
DYNJ47987A | LINE KIT |
DYNJ38885B | PEDIATRIC CENTRAL LINE KIT |
DYNJ60586 | PK CUST CENTRAL LINE PACK |
DYNDL1134A | TRAY LACERATION |
DYNJ67990 | TUNNEL LINE PACK |
DYNDV2385 | ULTRASOUND GUIDED IV/MIDLINE K |
- Amount recalled
- 19,907 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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