Home / Recalls / Medical Devices
MEDLINE INDUSTRIES, LP - Northfield recalls Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model N
Recalled August 9, 2023 · FDA recall Z-2294-2023 · MEDLINE INDUSTRIES, LP - Northfield
Hazard
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. · FDA Class II
Units
192 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 PEDIATRIC EP PACK, Model Number: DYNJ45158A
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →