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) 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;

MEDLINE INDUSTRIES, LP – Northfield Recall 92466 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2202-2023
Event ID92466
Event DescriptionMedline 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;
Product TypeDevices
DistributionWorldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Quantity572 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 CVI4770A, UDI/DI (EA) 10653160350828, UDI/DI (CS) 00653160350821; b) Model Number DT21275, UDI/DI (EA) 10653160318934, UDI/DI (CS) 00653160318937; c) Model Number EBSI1382, UDI/DI (EA) 10193489196269, UDI/DI (CS) 20193489196266; d) Model Number EBSI1464, UDI/DI (EA) 10193489198959, UDI/DI (CS) 20193489198956;
Center Classification Date20230720
Recall Initiation Date20230518
Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Initial Notification Letter
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