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Fresenius Medical Care Holdings, Inc. Recall 94084

Description: stay-safe /Luer Lock Adapter 4 in

Fresenius Medical Care Holdings, Inc. Recall 94084 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1324-2024
Event ID94084
Event Descriptionstay-safe /Luer Lock Adapter 4 in
Product TypeDevices
DistributionDomestic: Nationwide Distribution.
Quantity828,954 eaches
Recall ReasonThe peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Device Classification20240403
Device Code InfoModel Number: 050-95003; UDI/DI (Bag): 00840861100774; UDI/DI (Case): 10840861100771; All lots.
Center Classification Date20240326
Recall Initiation Date20240123
Recalling FirmFresenius Medical Care Holdings, Inc.
Initial Notification Letter
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