MEDLINE INDUSTRIES, LP - Northfield: 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;

Recall number

Z-2331-2023

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

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;

Status

Open, Classified

Initiated

2023-05-15

Posted

2023-08-03

Terminated

not on file

Reason

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Root cause

Nonconforming Material/Component

Action

Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OJG

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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