MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as PEDIATRIC EP PACK, Model Number: DYNJ45158A

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: 192 kits Lot/code info: Model Number: DYNJ45158A, UPC Number: 088827750721, all lot numbers distributed from Medline between 04/01/2020 and 04/28/2023.

UPC codes

088827750721

Source

Official record: FDA (Device enforcement) ↗

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