MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF

Recalled August 9, 2023 · FDA recall Z-2308-2023 · MEDLINE INDUSTRIES, LP - Northfield

Hazard

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

Units

1,130 kits

Sold at

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Description

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

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.

Manufacturer(s)

MEDLINE INDUSTRIES, LP - Northfield

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →