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Cardinal Health 200, LLC Recall 93676

Description: Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

Cardinal Health 200, LLC Recall 93676 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0858-2024
Event ID93676
Event DescriptionCardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
Product TypeDevices
DistributionDistribution US nationwide, Canada, Australia, LATAM (including Mexico, Colombia and Brazil), Netherlands.
Recall ReasonCardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
Device Classification20240214
Device Code InfoUDI/DI 26971564466206 (Case), 16971564466209 (Box), 06971564466202 (Each), Lot Numbers: 230701, 230501
Center Classification Date20240202
Recall Initiation Date20231228
Recalling FirmCardinal Health 200, LLC
Initial Notification Letter
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