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FDA (Device enforcement)Recalled 2024-10-16class ii

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

Hazard

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

Details from the source

Reason for recall: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Distribution: US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands Quantity: 5975 units Lot/code info: 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

UPC codes

10889942358311, 40889942358312, 10889942358328, 40889942358329

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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