Skip to content

MEDLINE Kits, trays, and packs labeled as follows recallZ-1102-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 15, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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 [email protected].

Recall details

Recall number
Z-1102-2024
Status
Open, Classified
Initiated by the company
Nov 15, 2023
Posted by the FDA
Feb 25, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
3297 units
Product code
FDE
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Product description

MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRIC CULTURE PACK, REF DYNJ53966AH; g) HERNIA, REF CDS982034R; h) HERNIA, REF CDS982034S; i) HERNIA PACK, REF DYNJ39331B; j) LAP APPY PACK, REF DYNJ37709J; k) LAP CHOLE CDS, REF CDS983912V; l) LAP CHOLE CDS, REF CDS983912W; m) LAP CHOLE CDS, REF CDS983912X; n) LAP CHOLE CDS, REF CDS983912Y; o) LAPAROSCOPY PACK, REF DYNJ41417J; p) LAPAROTOMY CDS-LF, REF CDS860091A; q) LOWER EXTREMITY, REF DYNJ46222M; r) MAJOR PACK, REF DYNJ80578A; s) MINOR PACK, REF DYNJ67217D; t) N L MINOR CDS, REF CDS982518O; u) N L MINOR CDS, REF CDS982518P; v) NON STERILE I&D KIT, REF DYKM1438; w) PACK,GU MINOR, REF DYNJ906885B; x) PLASTICS SUTURE TRAY, REF SUT13535; y) RESPIRATORY KIT, REF DYKM1404; z) TRACH CARE TRAY, REF DYNDJ1057A;

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

a) REF CDS983673G, UDI/DI 40193489951746 (case), 10193489951745 (unit), Lot Numbers: 22EDA378, 22EDB208; b) REF CDS983673I, UDI/DI 40195327147335 (case), 10195327147334 (unit), Lot Numbers: 22GBJ096, 22GBJ097, 22HBR769, 22KBN934, 23ABH521, 23ABM586, 23BBR709, 23DBL344; c) REF DYKM1425, UDI/DI 40889942511236 (case), 10889942511235 (unit), Lot Numbers: 22DLA695, 22FLA284, 22GLA016, 22ILA012, 22ILA463, 22KLA336, 23ALA341, 23BLA132, 23DLB048, 23ELA454, 23FLA774, 23HLA165, 23ILB030, 23JLA435; d) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers: 23EBC489; e) REF DYNJ53966A, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181; f) REF DYNJ53966AH, UDI/DI 40889942964681 (case), 10889942964680 (unit), Lot Numbers: 23CMB869, 23DMG880, 23EMG449, 23FMC889, 23HMA233, 23IMD181, g) REF CDS982034R, UDI/DI 40195327003740 (case), 10195327003739 (unit), Lot Numbers: 21LBB488, 21LBC635, 22HBW422; h) REF CDS982034S, UDI/DI 40195327295364 (case), 10195327295363(unit), Lot Numbers: 23ABB710, 23BBA114, 23EBB482; i) REF DYNJ39331B, UDI/DI 40889942731580 (case), 10889942731589 (unit), Lot Numbers: 22HBH194, 22JBE708, 22LBL321, 23GBV891, 23IBA384; j) REF DYNJ37709J, UDI/DI 40193489376075 (case), 10193489376074 (unit), Lot Numbers: 22FMG179; k) REF CDS983912V, UDI/DI 40195327057146 (case), 10195327057145 (unit), Lot Numbers: 22BBX974, 22DBG451, 22DBO438, 22FBM809; l) REF CDS983912W, UDI/DI 40195327238408 (case), 10195327238407 (unit), Lot Numbers: 22KBI248, 23CBC518, 23DBM244; m) REF CDS983912X, UDI/DI 40195327403141 (case), 10195327403140 (unit), Lot Numbers: 23EBK644; n) REF CDS983912Y, UDI/DI 40195327417827 (case), 10195327417826 (unit), Lot Numbers: 23FBS625, 23HBD741, 23HBO315, 23IBC397, 23IBM310; o) REF DYNJ41417J, UDI/DI 40195327220991 (case), 10195327220990 (unit), Lot Numbers: 23FBQ267; p) REF CDS860091A, UDI/DI 40884389018324 (case), 10884389018323 (unit), Lot Numbers: 22ABW443, 22CBU907, 22FMA320, 22GMH940, 22IMI179, 22KMA029, 23AMJ550, 23CMF095, 23FMI870, 23GMF353; q) REF DYNJ46222M, UDI/DI 40195327437566 (case), 10195327437565 (unit), Lot Numbers: 23GBP791; r) REF DYNJ80578A, UDI/DI 40195327063819 (case), 10195327063818 (unit), Lot Numbers: 22FBO880; s) REF DYNJ67217D, UDI/DI 40195327278022 (case), 10195327278021 (unit), Lot Numbers: 23DBC699, 23EBB789, 23GBC854, 23GBP633; t) REF CDS982518O, UDI/DI 40195327247387 (case), 10195327247386 (unit), Lot Numbers: 23ABD137; u) REF CDS982518P, UDI/DI 40195327318858 (case), 10195327318857 (unit), Lot Numbers: 23BBM210; v) REF DYKM1438, UDI/DI 40889942529965 (case), 10889942529964 (unit), Lot Numbers: 22DDB583, 22FDA732, 22HDA409, 22JDA278, 22LDA778, 23BDB559, 23FDC186, 23IDA954; w) REF DYNJ906885B, UDI/DI 40193489972543 (case), 10193489972542 (unit), Lot Numbers: 22GBF087; x) REF SUT13535, UDI/DI 40193489440271 (case), 10193489440270 (case), Lot Numbers: 23GBD750; y) REF DYKM1404, UDI/DI 40889942473831 (case), 10889942473830 (unit), Lot Numbers: 22JBQ565, 23CBG138, 23EBO035, 23EBW986, 23GBP589; z) REF DYNDJ1057A, UDI/DI 40888277204790 (case), 10888277204799 (unit), Lot Numbers: 23DBC974

Devices named in this recall

24 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93800).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page