Z-1706-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 7, 2025
- Initiation Date
- March 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2519991 units
Product Description
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Code Information
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.