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

Recall Z-2198-2023 — Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;

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-2198-2023
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): 10889942277360

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

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Recall Z-2198-2023 — Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ULTRASOUND PACK, Model Number DYNDH1112; b) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; c) ULTRASOUND TRAY, Model Number DYNDH1204;

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