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Recall Observatory FDA recall evidence

Device product

Medline Adult Anesthesia Set, REF DYNJ39985G

Z-0137-2026

September 10, 2025

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 97650
Status
Ongoing
Classification
Class II
Quantity
950 units
Official record key
device-enforcement:Z-0137-2026

Official wording

Reason: Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.

Code information: UDI/DI 10198459062353 (EA) 40198459062354 (Case), Lot Numbers: 25GMB464

Distribution pattern: US Nationwide distribution in the states of MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.