MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2175-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number CVI4880; b) CENTRAL CATHETER INSERTION TRA, Model Number CVI680C; c) CVL INSERTION TRAY, Model Number DYNDC1786A; d) UNIVERSAL INSERTION KIT, Model Number ECVC1655; e) CVC INSERTION ACCESSORY KIT, Model Number ECVC7880; f) ULTASOUND GUIDED PIV INSERTION, Model Number IVS3635B

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: July 26, 2023

Recall Number: Z-2175-2023

Event ID: 92466

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2739 units

Code Information:

all lots within expiry, distributed from Medline between December 2017 - May 2023: Model Number CVI4880, UDI/DI (EA) 10195327233976, UDI/DI (CS) 40195327233977; Model Number CVI680C, UDI/DI (EA) 10653160992943, UDI/DI (CS) 40653160992944; Model Number DYNDC1786A, UDI/DI (EA) 10193489199116, UDI/DI (CS) 40193489199117; Model Number ECVC1655, UDI/DI (EA) 10653160254935, UDI/DI (CS) 40653160254936; Model Number ECVC7880, UDI/DI (EA) 10195327129613, UDI/DI (CS) 40195327129614; Model Number IVS3635B, UDI/DI (EA) 10653160992660, UDI/DI (CS) 40653160992661

Distribution Pattern:

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated