MEDLINE INDUSTRIES, LP - Northfield: Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY, REF SUT19510; g) LACERATION TRAY, REF SUT8565; h) LACERATION TRAY, REF SUT8565; i) LINE REPAIR KIT, REF MNS12045A; j) MMC DAILY DRIVELINE MGMT KIT, REF DM850A; k) NEWBORN THORACOTOMY TRAY, REF MNS3470; l) NICU STERILE CENTRAL LINE CHANGE KIT, REF DT18520A; m) OMMAYA KITS - LATEX FREE, REF HT2375; n) PEDIATRIC ULTRASOUND KIT, REF MNS12995A; o) PORT ACCESS INFUSION KIT - 1IN NEEDLE, REF DYNDC2817C; p) WOUND CLOSURE AND IRRIGATION TRAY, REF SUT14785;

Recall number

Z-1132-2024

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY, REF SUT19510; g) LACERATION TRAY, REF SUT8565; h) LACERATION TRAY, REF SUT8565; i) LINE REPAIR KIT, REF MNS12045A; j) MMC DAILY DRIVELINE MGMT KIT, REF DM850A; k) NEWBORN THORACOTOMY TRAY, REF MNS3470; l) NICU STERILE CENTRAL LINE CHANGE KIT, REF DT18520A; m) OMMAYA KITS - LATEX FREE, REF HT2375; n) PEDIATRIC ULTRASOUND KIT, REF MNS12995A; o) PORT ACCESS INFUSION KIT - 1IN NEEDLE, REF DYNDC2817C; p) WOUND CLOSURE AND IRRIGATION TRAY, REF SUT14785;

Status

Open, Classified

Initiated

2023-11-15

Posted

2024-02-25

Terminated

not on file

Reason

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Root cause

Nonconforming Material/Component

Action

MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Quantity

14234 units

Distribution

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Lot, serial or model codes

a) MNS13600, 00653160349887 (case), 10653160349884 (unit), Lot Numbers: 2022022350, 2022041880; b) DM640A, 00653160357271 (case), 10653160357278 (unit), Lot Numbers: 2022122090, 2022122890, 2023073190; c) CIT6180, 00653160290691 (case), 10653160290698 (unit), Lot Numbers: 2023080290; d) ID1690, 10653160235903 (case), 00653160235906 (unit), Lot Numbers: 2022071390, 2022120790, 2023062690; e) SUT19510, 00653160352436 (case), 10653160352433 (unit), Lot Numbers: 2022041880, 2022071180, 2022071280; f) SUT19510, 00653160356199 (case), 10653160356196 (unit), Lot Numbers: 2022120290, 2023033090, 2023052290, 2023080190; g) SUT8565, 50653160016845 (case), 00653160016840 (unit), Lot Numbers: 2022042580; h) SUT8565, 00653160356182 (case), 10653160356189 (unit), Lot Numbers: 2023020690, 2023030390, 2023050390, 2023091890; i) MNS12045A, 00653160350340 (case), 10653160350347 (unit), Lot Numbers: 2022032850, 2022041180, 2022041280; j) DM850A, 00653160354096 (case), 10653160354093 (unit), Lot Numbers: 2022072890, 2022090690, 2022112290, 2023030390, 2023070390; k) MNS3470, 10653160106029 (case), 00653160106022 (unit), Lot Numbers: 2022031790, 2022091390, 2022110890, 2023011690, 2023052290, 2023080790; l) DT18520A, 00653160351491 (case), 10653160351498 (unit), Lot Numbers: 2022082280, 2022082980; m) HT2375, 50653160050221 (case), 00653160050226 (unit), Lot Numbers: 2023061290, 023092190; n) MNS12995A, 00653160349818 (case), 10653160349815 (unit), Lot Numbers: 2022031750, 2022031850, 2022082980; o) DYNDC2817C, 00653160348361 (case), 10653160348368 (unit), Lot Numbers: 2022012480, 2022050980; p) SUT14785, 10653160193081 (case), 00653160193084 (unit), Lot Numbers: 2022060290, 2022110490, 2023040390, 2023052490, 2023061390, 2023091490

510(k) numbers

not on file

PMA numbers

not on file

Product code

LRP

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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