Skip to content

Medline procedure kits, labeled as recallZ-1709-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 19, 2025

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

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline Industries issued an IMMEDIATE ACTION REQUIRED recall notice to its consignees on 03/19/2025 via email and US mail. The notice explained the issue, potential risk and requested all affected product be destroyed. Credit will be issued upon receipt of completed destruction form. Those who have transferred or further distributed the product were directed to notify those to whom the product was transferred or distributed. For questions contact 866-359-1704 or email [email protected].

Recall details

Recall number
Z-1709-2025
Status
Open, Classified
Initiated by the company
Mar 19, 2025
Posted by the FDA
May 1, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
822 units
Product code
LRO
Distribution
Worldwide distribution - US Nationwide and the countries of Panama and Canada.

Product description

Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC1024A.

Code information (models, lots, serial numbers)

1) REF DYNDA1359A: UDI/DI 10195327417734 (EA) 40195327417735 (CS), Lot Numbers: 23KBW508; 2) REF DYNDA1360B: UDI/DI 10889942903863 (EA) 40889942903864 (CS), Lot Numbers: 23KBB406; 3) REF DYNDC1311C: UDI/DI 10080196151561 (EA) 40080196151562 (CS), Lot Numbers: 23KBX338; 4) REF DYNDC3185: UDI/DI 10195327034108 (EA) 40195327034109 (CS), Lot Numbers: 23KBX632; 5) REF EDUC05015A: UDI/DI 10193489849035 (EA) 40193489849036 (CS), Lot Numbers: 23LDA746, 23LDA814, 23LDA218; 6) REF EDUC1024A: UDI/DI 10195327493165 (EA) 40195327493166 (CS), Lot Numbers: 23LDA281, 23KDA001.

Devices named in this recall

6 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 96630).

Sources and updates

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