Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1106-2024 — MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H

U.S. FDA — Device Enforcement · United States · 2023-11-15 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1106-2024
Date of alert
2023-11-15
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
MEDLINE INDUSTRIES, LP - Northfield
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
40193489339797
Reported risk: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.