MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66

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: 9,319 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: DYNJ66041A, UPC Number: 019348948028; Model Number: DYNJ66041B, UPC Number: 019532715107. b. Model Number: DYNJ62319A, UPC Number: 019348947486; Model Number: DYNJ62319B, UPC Number: 019348999548. c. Model Number: DYNDV2397, UPC Number: 019348938846. d. Model Number: DYNJ24276C, UPC Number: 088438943118. e. Model Number: DYNJ27275, UPC Number: 008019683311.

UPC codes

019348948028, 019532715107, 019348947486, 019348999548, 019348938846, 088438943118, 008019683311

Source

Official record: FDA (Device enforcement) ↗

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