FDA recall Z-1709-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

Key facts

Status
Ongoing
Initiation date
2025-03-19
Report date
2025-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1709-2025