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

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770A; b) INSERTION BUNDLE, Model Number DT21275; c) VA MAINTENANCE PACK, Model Number EBSI1382; d) MIDLINE DRESSING CHANGE KIT, Model Number EBSI1464; — recall Z-2202-2023

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-2202-2023
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): 10653160350828

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

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.

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