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Recall Observatory FDA recall evidence

Device product

MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20

Z-0510-2025

October 16, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95615
Status
Ongoing
Classification
Class II
Quantity
5975 units
Official record key
device-enforcement:Z-0510-2025

Official wording

Reason: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Code information: Codes: 1) EPICATH19, UDI/DI 10889942358311(each) 40889942358312(case), Lot Numbers: 22FBX111, 22FBY472, 23FBT886, 23GBL403, 23GBO700, 23GBO701, 23GBO702; 2) EPICATH20, UDI-DI: 10889942358328 (each) 40889942358329 (case), Lot Numbers: 22FBN457, 22HBM699, 22HBN345, 23CBF321, 23DBM670, 23FBK248, 23GBO703, 23GBO704 23GBO705, 23KBG553, 23KBS111

Distribution pattern: US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.