Reported Sep 4, 2024 · Ongoing
Medline procedure packs containing Shenli syringes, labeled as follows
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?
Medline procedure packs containing Shenli syringes, labeled as follows
7 of 7 products
| Model / number | Product as published |
|---|---|
DYNDA1431A | NEURO ANGIO PACK |
ECVC3260 | CVC INSERT BUNDLE 16CM |
ECVC7440 | CENTRAL LINE INSERTION KIT |
ECVC7445 | CENTRAL LINE INSERTION KIT |
ECVC7445A | CENTRAL LINE INSERTION KIT W/20CM CATH |
ECVC8045 | VANTEX 7FR 3L 20CM CVC BUNDLE US |
ECVC8105 | CVC DOUBLE LUMEN 16CM |
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 DYNDA1431A, Lot Number 2019021190 2 ECVC3260, Lot Number 2019091850 3 ECVC3260, Lot Number 2019120950 4 ECVC7440, Lot Number 2021071950 5 ECVC7440, Lot Number 2021092150 6 ECVC7445, Lot Number 2021052850 7 ECVC7445, Lot Number 2021062250 8 ECVC7445A, Lot Number 2022012850 9 ECVC7445A, Lot Number 2023010390 10 ECVC8045, Lot Number 2023031590 11 ECVC8105, Lot Number 2023112190 - Amount recalled
- 1,679,067 units in total
This recall covers 55 products
The agency filed one notice per product. You are reading one of them; the other 54 are below.
42 more are in the archive.
Why it was recalled
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
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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