MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PR

Hazard

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Details from the source

Reason for recall: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates. Quantity: 1,231,480 kits Lot/code info: a. Model Number DYNJE5900; UDI-DI Each: 10884389114124, Case: 40884389114125; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920050011, 06920050011, 06920050011, 06920050011, 06920050011, 06920050011, 06920070011, 06920080012, 06920100011, 06920100011, 06920110011, 06920120011, 06920120011, 06921010011, 06921010011, 06921010022, 06921020011, 06921020021, 06921030021, 06921030031, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921050011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921090012, 06921100011, 06921100012, 06921100012, 06921110011, 0692112H022, 0692112H022, 0692112H022, 0692201H011, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692205H011, 0692205H011; b. Model Number DYNJE5910; UDI-DI Each: 10884389114094, Case: 40884389114095; Lot Numbers: 06920120011, 06920120011, 06921010011, 06921030011, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921110011, 06921120011, 0692112H022, 0692112H022, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692208H014; c. Model Number DYNJE5920; UDI-DI Each: 10884389114100, Case: 40884389114101; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920040022, 06920050011, 06920050011, 06920050011, 06920070011, 06920080012, 06920090011, 06920

UPC codes

10884389114124, 40884389114125, 06920030012, 06920030021, 06920040022, 06920050011, 06920070011, 06920080012, 06920100011, 06920110011, 06920120011, 06921010011, 06921010022, 06921020011, 06921020021, 06921030021, 06921030031, 06921040011, 06921050011, 06921060011, 06921070011, 06921080011, 06921090011, 06921090012, 06921100011, 06921100012, 06921110011, 10884389114094, 40884389114095, 06921030011, 06921120011, 10884389114100, 40884389114101, 06920090011, 06920120012, 06921030012, 06921100013, 10884389114117, 40884389114118, 06920050012

Source

Official record: FDA (Device enforcement) ↗

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