MEDLINE INDUSTRIES, LP - Northfield: Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF DYNDA2369A; h) CENTRAL LINE NEEDLELESS CONNECTOR KIT, REF DYNDC2869B; i) CVC STERILE CAP CHANGE KIT, REF DT20900A; j) DOUBLE VALVE CHANGE KIT, REF DYNDA2660A; k) KIDNEY BIOPSY PACK, REF DYNDH1650; l) PORT ACCESS INFUSION KIT - 0.75IN NEEDLE, REF DYNDC2816C; m) PORT ACCESS KIT, REF EBSI1302A; n) SHORT TERM INFUSAPORT ACCESS KIT, REF DYNDC3188; o) SINGLE VALVE CHANGE KIT, REF DYNDA2659A; p) SUTURE TRAY, REF DYNDS1085A;

Recall number

Z-1112-2024

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF UVT840A g) BRONCHOALVEOLAR LAVAGE PACK, REF DYNDA2369A; h) CENTRAL LINE NEEDLELESS CONNECTOR KIT, REF DYNDC2869B; i) CVC STERILE CAP CHANGE KIT, REF DT20900A; j) DOUBLE VALVE CHANGE KIT, REF DYNDA2660A; k) KIDNEY BIOPSY PACK, REF DYNDH1650; l) PORT ACCESS INFUSION KIT - 0.75IN NEEDLE, REF DYNDC2816C; m) PORT ACCESS KIT, REF EBSI1302A; n) SHORT TERM INFUSAPORT ACCESS KIT, REF DYNDC3188; o) SINGLE VALVE CHANGE KIT, REF DYNDA2659A; p) SUTURE TRAY, REF DYNDS1085A;

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

21154 units

Distribution

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

Lot, serial or model codes

a) REF SUT13935, UDI/DI 40193489440714 (case), 10193489440713 (unit), Lot Numbers: 23GBO782, 23GBP869, 23HBA879, 23HBX374; b) REF SUT21215, UDI/DI 653160325645 (case), 10653160325642 (unit), Lot Numbers: 22EBB078, 22FBE772, 22GBJ917, 22HBN681, 22HBW656, 22JBB835, 23ABL668, 23FBT868, 23GBK697, 23HBU987; c) REF SUT15380, UDI/DI 10653160203698 (case), 653160203691 (unit), Lot Numbers: 22EBI572, 22FBK706, 22GBI140, 22GBZ790, 22JBT097, 22KBW287, 22LBS262, 23DBB365, 23EBB439, 23EBS520, 23FBV416, 23HBV213; d) REF SUT19005, UDI/DI 653160271454 (case), 10653160271451 (unit), Lot Numbers: 23CBV894, 23EBM160, 23FBI594, 23GBK013, 23HBW722; e) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (unit), Lot Numbers: 22FBG265, 22FBU120, 22HBK650, 22LBS268, 23CBH315, 23EBH269, 23HBU983; f) REF UVT840A, UDI/DI 653160292008 (case), 10653160292005 (unit), Lot Numbers: 22ABH461, 22ABJ736; g) REF DYNDA2369A, UDI/DI 00653160352160 (case), 10653160352167 (unit), Lot Numbers: 2022051050, 2022072750; h) REF DYNDC2869B, UDI/DI 20193489111719 (case), 10193489111712 (unit), Lot Numbers: 2021121750, 2022010450; i) REF DT20900A, UDI/DI 00653160353211 (case), 10653160353218 (unit), Lot Numbers: 2022061380, 2022061480, 2022082280; j) REF DYNDA2660A, UDI/DI 00653160351897 (case), 10653160351894 (unit), Lot Numbers: 2022042580, 2022050280, 2022082280; k) REF DYNDH1650, UDI/DI 20193489110866 (case), 10193489110869 (unit), Lot Numbers: 2022012050; l) REF DYNDC2816C, UDI/DI 00653160348309 (case), 10653160348306 (unit), Lot Numbers: 2022041880; m) REF EBSI1302A, UDI/DI 20193489111894 (case), 10193489111897 (unit), Lot Numbers:2022020250, 2022022880, 2022082280; n) REF DYNDC3188, UDI/DI 00653160348828 (case), 10653160348825 (unit), Lot Numbers: 2022012450; o) REF DYNDA2659A, UDI/DI 00653160351880 (case), 10653160351887 (unit), Lot Numbers: 2022042850; p) REF DYNDS1085A, UDI/DI 40080196778691 (case), 10080196778690 (unit), Lot Numbers: 2022041150, 2022051350, 2022053150

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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