MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CATH LAB BASIN PACK, Model Number: DYNJ69864A; b. DE

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: 1,182 kits Lot/code info: All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ69864A, UPC Number: 019532713205. b. Model Number: DYNJ82257, UPC Number: 019532718165. c. Model Number: DYNJ60224C, UPC Number: 019532715184.

UPC codes

019532713205, 019532718165, 019532715184

Source

Official record: FDA (Device enforcement) ↗

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