Z-2174-2023 Class II Ongoing
FDA device recall Z-2174-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on May 18, 2023 and is designated Class II. Reason for recall: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. The recall status is ongoing. Affected quantity: 25 units.
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
- 25 units
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
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 DYNJ60126Bm UDI/DI (EA) 10195327118839, UDI/DI (CS) 40195327118830