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

Recall Z-1103-2024 — MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222; h) LAP CHOLE CDS,

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-1103-2024
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): 40195327279951

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.

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.

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