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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0858-2024 |
Event ID | 93676 |
Event Description | Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE |
Product Type | Devices |
Distribution | Distribution US nationwide, Canada, Australia, LATAM (including Mexico, Colombia and Brazil), Netherlands. |
Recall Reason | Cardinal 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 Classification | 20240214 |
Device Code Info | UDI/DI 26971564466206 (Case), 16971564466209 (Box), 06971564466202 (Each), Lot Numbers: 230701, 230501 |
Center Classification Date | 20240202 |
Recall Initiation Date | 20231228 |
Recalling Firm | Cardinal Health 200, LLC |
Initial Notification | Letter |
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