PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: May 7, 2025 Initiated: March 19, 2025 #Z-1709-2025

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.

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.

Details

Units Affected
822 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 822 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 7, 2025. Severity: Moderate. Recall number: Z-1709-2025.