MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CHP COCHLEAR SUPPLEMENT CDS, Model Number CDS983069I; b) HEAD AND NECK PAC

Hazard

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

Details from the source

Reason for recall: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. Distribution: Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia. Quantity: 1861 units Lot/code info: all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS983069I, UDI/DI (EA) 10195327071868, UDI/DI (CS) 40195327071869; b) Model Number DYNJ30245, UDI/DI (EA) 10080196787692, UDI/DI (CS) 40080196787693; c) Model Number DYNJ47716B, UDI/DI (EA) 10193489454536, UDI/DI (CS) 40193489454537; d) Model Number DYNJ63347A, UDI/DI (EA) 10193489278064, UDI/DI (CS) 40193489278065; e) Model Number DYNJ63634A, UDI/DI (EA) 10195327143046, UDI/DI (CS) 40195327143047; f) Model Number DYNJ81389A, UDI/DI (EA) 10195327176785, UDI/DI (CS) 40195327176786; g) Model Number DYNJ83960, UDI/DI (EA) 10195327319991, UDI/DI (CS) 40195327319992; h) Model Number DYNJ907206D, UDI/DI (EA) 10195327307011, UDI/DI (CS) 40195327307012;

UPC codes

10195327071868, 40195327071869, 10080196787692, 40080196787693, 10193489454536, 40193489454537, 10193489278064, 40193489278065, 10195327143046, 40195327143047, 10195327176785, 40195327176786, 10195327319991, 40195327319992, 10195327307011, 40195327307012

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.