Product Safety Recalls

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MEDLINE INDUSTRIES, LP – Northfield Recall 92466

Description: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;

MEDLINE INDUSTRIES, LP – Northfield Recall 92466 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2195-2023
Event ID92466
Event DescriptionMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETERLESS INSERTION KIT, Model Number CVI4510; b) VANTEX 7FR 3L 16CM CVC BUNDLE, Model Number STCVC01145B; c) VANTEX TRIPLE LUMEN BUNDLE, Model Number STCVC2000;
Product TypeDevices
DistributionWorldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Quantity620 units
Recall ReasonProbe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Device Classification20230726
Device Code InfoAll lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CVI4510, UDI/DI (EA) 10653160321194, UDI/DI (CS) 00653160321197; b) Model Number STCVC01145B, UDI/DI (EA) 10653160351924, UDI/DI (CS) 00653160351927; c) Model Number STCVC2000, UDI/DI (EA) 10653160336792, UDI/DI (CS) 00653160336795
Center Classification Date20230720
Recall Initiation Date20230518
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Initial Notification Letter
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