Recall Z-1706-2025

MEDLINE INDUSTRIES, LP - Northfield · initiated March 19, 2025

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296

Codes / lots: UDI/DI 10884389338247 (EA) 10884389338230 (CS), Lot Numbers: 23DJA038, 23DJA070, 23DJA114, 23EJA057, 23EJA128, 23EJA144, 23FJA110, 23GJA041, 23GJA118, 23GJA132, 23HJA033, 23IJA045, 23IJA052, 23IJA102, 23JJA103, 23JJA119, 23JJA144, 23LJA114, 24AJA025, 24AJA061, 24AJA180, 24BJA038, 24BJA092, 24BJA119, 24BJA158, 24CJA048, 24CJA117, 24CJA147, 24DJA010, 24HJA075, 24HJA178, 24KJA148.

Reason for recall

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-determined cause: Under Investigation by firm

Action taken

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 Recalls@Medline.com.

Details

Recall number
Z-1706-2025
Initiated
March 19, 2025
Posted by FDA
May 1, 2025
Product code
FRO – Dressing, Wound, Drug
Quantity
2519991 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1705-2025 Class IIMedline Sterile Water, USP, 100mL, REF RDI30295It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified
Z-1707-2025 Class IIMedline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified
Z-1708-2025 Class IIMedline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified
Z-1709-2025 Class IIMedline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK…It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified
Z-1710-2025 Class IIMedline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified
Z-1711-2025 Class IIMedline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION…It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified
Z-1712-2025 Class IIMedline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001AIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified
Z-1713-2025 Class IIMedline procedure kits, labeled as: OL OCULAR, REF DYNJ906183KIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified
Z-1714-2025 Class IIMedline procedure kits, labeled as: HAND, REF DYNJ902002JIt was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking… 03/19/2025Open, Classified