Skip to content
Recall Observatory FDA recall evidence

Device product

Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) VANTEX 7FR 3L 20CM CVC BUNDLE US, Pack Number ECVC8045

Z-2629-2024

April 08, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 94582
Status
Ongoing
Classification
Class II
Quantity
1,679,067 units in total
Official record key
device-enforcement:Z-2629-2024

Official wording

Reason: 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.

Code information: 1) ECVC3260, Lot Number 2018052950; 2) ECVC8045, Lot Number 2023110290

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.