Custom Sterile and Non-Sterile Procedural Kits recall: Sterility Concern

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ905151A, UPC Number: 019348981341. b. Model Number: DYNJ58346A, UPC Number: 019348977463. c. Model Number: DYNJ57442C, UPC Number: 019348920853; Model Number: DYNJ64081A, UPC Number: 019348927374. d. Model Number: DYNJ65963, UPC Number: 019348930770. e. Model Number: DYNJ64655, UPC Number: 019348921040. f. Model Number: SPEC0232, UPC Number: 088827750741. g. Model Number: DYNJ62591A, UPC Number: 019348979331. h. Model Number: DYNJ39752A, UPC Number: 088438990723. i. Model Number: DYNJ53064B, UPC Number: 019348978916. j. Model Number: DYNJ64050, UPC Number: 019348978046. k. Model Number: DYKMBNDL148, UPC Number: 019348947839. l. Model Number: DYNJ0878178I, UPC Number: 019348956435. m. Model Number: DYNJ57760A, UPC Number: 019348922023. n. Model Number: DYNJ57032C, UPC Number: 019348945147. o. Model Number: DYNJ39198L, UPC Number: 019348956435 Model Number: DYNJ39198N, UPC Number: 019532710200. p. Model Number: DYNJ906086A, UPC Number: 019348920868. q. Model Number: DYNJ908260, UPC Number: 019532701744. r. Model Number: DYNJ66790, UPC Number: 019348938243; Model Number: DYNJ66790A, UPC Number: 019348992247; Model Number: DYNJ66790B, UPC Number: 019532709926. s. Model Number: DYNJ69129, UPC Number: 019348989241; Model Number: DYNJ83090, UPC Number: 019532723093. t. Model Number: DYNJ35066I, UPC Number: 019348956435; Model Number: DYNJ35066J, UPC Number: 019532709107; Model Number: DYNJ60701A, UPC Number: 019348969378; Model Number: DYNJ60701B, UPC Number: 019348987733; Model Number: DYNJ60701C, UPC Number: 019532703379. u. Model Number: DYNJ43934A, UPC Number: 019348973360; Model Number: DYNJ61798D, UPC Number: 019348999263; Model Number: DYNJ66241, UPC Number: 019348932296; Model Number: DYNJ66241A, UPC Number: 019348993803; Model Number: DYNJ66241B, UPC Number: 019532705348; Model Number: DYNJ66241C, UPC Number: 019532709685; Model Number: DYNJ66241D, UPC Number: 019532713837; Model Number: DYNJ68956A, UPC Number: 019348987629; Model Number: DYNJ68956B, UPC Number: 019532709434. v. Model Number: DYNJ51107A, UPC Number: 019348971558; Model Number: DYNJ59903A, UPC Number: 019532704286; Model Number: DYNJ59903B, UPC Number: 019532713120. w. Model Number: DYNJ67075, UPC Number: 019348938847; Model Number: DYNJ67075A, UPC Number: 019532705453. x. Model Number: DYNJ60112A, UPC Number: 019348924703. y. Model Number: PHS41743B, UPC Number: 019348978493. z. Model Number: DYNJ54755C, UPC Number: 019348977837. aa. Model Number: DYNJ61449, UPC Number: 019348956734. bb. Model Number: DYNJ82393A, UPC Number: 019532729232.

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIO, Model Number: DYNJ905151A; b. ANGIO/VENO PACK, Model Number: DYNJ58346A; c. ANGIOGRAPHIC PACK, Model Number: DYNJ57442C, DYNJ64081A; d. ANGIOGRAPHY PACK, Model Number: DYNJ65963; e. ANGIOPLASTY PACK-LF, Model Number: DYNJ64655; f. ARTHROGRAM TRAY, Model Number: SPEC0232; g. BASIC CATH/ANGIO, Model Number: DYNJ62591A; h. BASIC PACK, Model Number: DYNJ39752A; i. C.I.C.N. ANGIO PACK, Model Number: DYNJ53064B; j. CATH ANGIO PACK, Model Number: DYNJ64050; k. DBD-KIT NEURO CAROTID SETUP, Model Number: DYKMBNDL148; l. DBS PACK-LF, Model Number: DYNJ0878178I; m. GENERAL ANGIO PACK, Model Number: DYNJ57760A; n. GHIASSI NEURO ANGIO PACK-LF, Model Number: DYNJ57032C; o. IR NEURO PACK, Model Number: DYNJ39198L, DYNJ39198N; p. KIT OR AORTOGRM ANGIOPLAST PHT, Model Number: DYNJ906086A; q. MAIN BASIC NEURO, Model Number: DYNJ908260; r. NEURO ACCESSORY PACK, Model Number: DYNJ66790, DYNJ66790A, DYNJ66790B; s. NEURO CATH PACK, Model Number: DYNJ69129, DYNJ83090; t. NEURO IR PACK, Model Number: DYNJ35066I, DYNJ35066J, DYNJ60701A, DYNJ60701B, DYNJ60701C; u. NEURO PACK, Model Number: DYNJ43934A, DYNJ61798D, DYNJ66241, DYNJ66241A, DYNJ66241B, DYNJ66241C, DYNJ66241D, DYNJ68956A, DYNJ68956B; v. NEURO RADIOLOGY PACK, Model Number: DYNJ51107A, DYNJ59903A, DYNJ59903B; w. NEURO TRAY, Model Number: DYNJ67075, DYNJ67075A; x. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112A; y. PEDI ANGIO PACK-LF, Model Number: PHS41743B; z. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755C; aa. RADIOLOGY NEURO DRAPE PAC, Model Number: DYNJ61449; bb. RO-DIEP PACK, Model Number: DYNJ82393A;

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Quantity

15,945 kits

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Recall date

August 9, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)