MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- REF
- DYNDA1359A: UDI/DI 10195327417734 (EA) 40195327417735 (CS)
- Lot #
- 23KBW508; 2)
- REF
- DYNDA1360B: UDI/DI 10889942903863 (EA) 40889942903864 (CS)
- Lot #
- 23KBB406; 3)
- REF
- DYNDC1311C: UDI/DI 10080196151561 (EA) 40080196151562 (CS)
- Lot #
- 23KBX338; 4)
- REF
- DYNDC3185: UDI/DI 10195327034108 (EA) 40195327034109 (CS)
- Lot #
- 23KBX632; 5)
- REF
- EDUC05015A: UDI/DI 10193489849035 (EA) 40193489849036 (CS)
- Lot #
- 23LDA746, 23LDA814, 23LDA218; 6)
- REF
- EDUC1024A: UDI/DI 10195327493165 (EA) 40195327493166 (CS)
- Lot #
- 23LDA281, 23KDA001
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What the firm 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 Recalls@Medline.com.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Panama and Canada.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1709-2025
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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