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Fresenius Medical Care Holdings, Inc. Recall 93396

Description: Stay Safe Cap

Fresenius Medical Care Holdings, Inc. Recall 93396 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0507-2024
Event ID93396
Event DescriptionStay Safe Cap
Product TypeDevices
DistributionUS Nationwide distribution.
Quantity18,236,160 eaches
Recall ReasonUpdating the labeling to include additional warnings and contraindications for potential side effects.
Device Classification20231213
Device Code InfoModel No. 050-95012; UDI-DI: 00840861100835; All Lots.
Center Classification Date20231207
Recall Initiation Date20231010
Recalling FirmFresenius Medical Care Holdings, Inc.
Initial Notification Letter
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