MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DBD-PACK FETOSCOPY, Model Number: DYNJ906905B; b. FE

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: 4,618 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: DYNJ906905B, UPC Number: 019348988494. b. Model Number: CDS840215O, UPC Number: 019348944899. c. Model Number: DYNJ906905A, UPC Number: 019348939112. d. Model Number: DYNDH1187A, UPC Number: 088994270263.

UPC codes

019348988494, 019348944899, 019348939112, 088994270263

Source

Official record: FDA (Device enforcement) ↗

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