Z-2154-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- May 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,505,262 kits
Product Description
Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures
Reason for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Code Information
All lots within expiry, distributed from Medline between December 2017 May 2023: Model Number (GTIN Number): DYNJE5900 (Each: 10884389114124, Case: 40884389114125), DYNJE5910 (Each: 10884389114094, Case: 40884389114095), DYNJE5920 (Each: 10884389114100, Case: 40884389114101), DYNJE5930 (Each: 10884389114117, Case: 40884389114118), DYNJE5940 (Each: 10888277723641, Case: 20888277723648), DYNJEX5900 (Each: 10884389114124, Case: 40884389114125). All lots within their expiration date.