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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Number ACC010809; 2) RESP/INTUBATION DRAWER #2, Model Number ACC010813

Z-1183-2025

January 09, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96188
Status
Ongoing
Classification
Class II
Quantity
0 kits
Official record key
device-enforcement:Z-1183-2025

Official wording

Reason: Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.

Code information: 1) ACC010809, UDI-DI 10198459012235 (each) 40198459012236 (case), Lot Number 24JDC400; 2) ACC010813, UDI-DI 10198459012556 (each) 40198459012557 (case), Lot Number 24KDA437

Distribution pattern: US States: CA, NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.