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Recall Observatory FDA recall evidence

Device product

ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A

Z-3072-2024

June 18, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95127
Status
Ongoing
Classification
Class II
Quantity
315 units
Official record key
device-enforcement:Z-3072-2024

Official wording

Reason: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.

Code information: UDI/DI Case 40195327334209, UDI/DI Each 10195327334208; Lot Numbers: 23IBJ309, 23GBA500, 23GBA457, 23CBE394, 23BBL312

Distribution pattern: US: TX, IL, CA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    non-sterile Mastisol component, which was not labeled as being sterile or non-sterile