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

Recall Z-2193-2023 — Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) RADIAL ARTERIAL LINE KIT, Model Number ART1070A; b) ARTERIAL LINE START KIT, Model Number ART1160; c) ARTERIAL LINE TRAY W/O CATHETER, Model Number ART1180; d) ARTERIAL LINE INSERTION KIT, Model Number AR

U.S. FDA — Device Enforcement · United States · 2023-05-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2193-2023
Date of alert: 2023-05-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: MEDLINE INDUSTRIES, LP - Northfield
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10653160358329

Reported risk: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

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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