MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b

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: 1,218 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: STCVC2020, UPC Number: 10653160338765. b. Model Number: ART905, UPC Number: 10653160326557. c. Model Number: CVI4510, UPC Number: 10653160321194. d. Model Number: ECVC7165A, UPC Number: 10653160346760. e. Model Number: STCVC01145B, UPC Number: 10653160351924. f. Model Number: STCVC2000, UPC Number: 10653160336792.

UPC codes

10653160338765, 10653160326557, 10653160321194, 10653160346760, 10653160351924, 10653160336792

Source

Official record: FDA (Device enforcement) ↗

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