MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825

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: 41,123 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: DYNJ0842825D, UPC Number: 019532728861. b. Model Number: DYNJ49933I, UPC Number: 019348947168; Model Number: DYNJ49933J, UPC Number: 019532706561. c. Model Number: DYNJ44808G, UPC Number: 019348987585. d. Model Number: DYNJ51304B, UPC Number: 088994236595; Model Number: DYNJ51304C, UPC Number: 019348946098. e. Model Number: DYNJ0678934D, UPC Number: 019348956435; Model Number: DYNJ0678934F, UPC Number: 019348956435; Model Number: DYNJ82567, UPC Number: 019532719803. f. Model Number: DYNJ0676055N, UPC Number: 019348956435. g. Model Number: DYNJ63343A, UPC Number: 019348929199; Model Number: DYNJ63343B, UPC Number: 019348947045; Model Number: DYNJ63343D, UPC Number: 019348996760; Model Number: DYNJ63343F, UPC Number: 019532708613; Model Number: DYNJ908880, UPC Number: 019532720343. h. Model Number: CDS983394I, UPC Number: 019348981995; Model Number: CDS983394J, UPC Number: 019532706987; Model Number: CDS983394K, UPC Number: 019532729258. i. Model Number: DYNJVB91067, UPC Number: 019348980153. j. Model Number: DYNJ906354D, UPC Number: 019348998657; Model Number: DYNJ906354F, UPC Number: 019532702150. k. Model Number: DYNJ0678934I, UPC Number: 019348999786; Model Number: DYNJ44934F, UPC Number: 019348944613; Model Number: DYNJ905726C, UPC Number: 019348994337; Model Number: DYNJ905726D, UPC Number: 019532716151. l. Model Number: DYNJ42831F,

UPC codes

019532728861, 019348947168, 019532706561, 019348987585, 088994236595, 019348946098, 019348956435, 019532719803, 019348929199, 019348947045, 019348996760, 019532708613, 019532720343, 019348981995, 019532706987, 019532729258, 019348980153, 019348998657, 019532702150, 019348999786, 019348944613, 019348994337, 019532716151, 019348988032, 019348942917, 019348983224, 019348991204, 019532734136, 019532704584, 019532701586, 019532702571, 019532728485, 019532700730, 019532705970, 019532735517, 019532705357, 019532713598, 019348943071, 019348996776, 019348946784

Source

Official record: FDA (Device enforcement) ↗

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