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Recall Observatory FDA recall evidence

Device product

Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.

Z-1711-2025

March 19, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96630
Status
Ongoing
Classification
Class II
Quantity
5200 units
Official record key
device-enforcement:Z-1711-2025

Official wording

Reason: 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.

Code information: 1) REF DYNDA1412A: UDI/DI 10193489693423 (EA) 40193489693424 (CS), Lot Numbers: 23KBH040; 2) REF DYNDL1263A: UDI/DI 10884389347126 (EA) 40884389347127 (CS), Lot Numbers: 23KBD401.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.