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 |
|---|---|
ECVC475 | MULTI-LUMEN CVC BUNDLE KIT |
ECVC3900 | MULTI-LUMEN CVC INSERTION BUNDLE |
STCVC20US | MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US |
STCVC21US | MULTIMED 7F 2L 16CM STOCK + BUNDLE US |
ECVC6585A | MULTIMED 7F 3L 16CM CVC BUNDLE |
ECVC7235A | MULTIMED 7F 3L 20CM PI |
STCVC03US | MULTIMED 7FR 16CM CVC STK + BUNDLE-US |
ECVC6655A | MULTIMED 7FR 3L 16CM CVC BUNDLE |
ECVC7935 | MULTIMED 7FR 3L 20CM CVC BUNDLE-US |
STCVC04US | MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US |
ECVC7670 | MULTIMED 7FR, 20CM, 3L CVC BUNDLE |
ECVC7090 | MULTIMED 8.5F 20CM QUAD CVC BUNDLE |
ECVC6930 | MULTIMED 8.5FR 16CM QUAD CVC BUNDLE |
STCVC13US | MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US |
DYNJ47646D | NEURO CATH PACK (NCLUA)227-LF, , DYNJ47646F, DYNJ47646G, DYNJ47646I |
ECVC8010 | O.R. DOUBLE LUMEN INSERTION TRAY |
ECVC4615 | OLEAN GENERAL CVC BUNDLE |
DYNJ59184B | OR ANGIO PACK |
DYNJ909267 | OR ANGIOGRAM |
DYNJ906297D | OR ANGIOGRAPHY DRAPE |
- Amount recalled
- 104,755 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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