Z-1783-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2026
- Initiation Date
- March 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1872 units
Product Description
COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, Order Number G44432.
Reason for Recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Distribution Pattern
Worldwide distribution.
Code Information
Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, UDI (01)00827002564244(17)261130(10)16288039, Lot Number 16288039; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, UDI (01)00827002210530(17)260430(10)16029543, Lot Number 16029543; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15681111, Lot Number 15681111; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15646726, Lot Number 15646726; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260228(10)15721094, Lot Number 15721094; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260131(10)15620729, Lot Number 15620729; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260131(10)15583884, Lot Number 15583884; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15518185, Lot Number 15518185; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15473132, Lot Number 15473132; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15489080, Lot Number 15489080; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)261130(10)15971893, Lot Number 15971893; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15496527, Lot Number 15496527; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251231(10)15484931, Lot Number 15484931; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)251219(10)15466662, Lot Number 15466662; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260930(10)15970575, Lot Number 15970575; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16240911, Lot Number 16240911; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270131(10)16042197, Lot Number 16042197; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16285631, Lot Number 16285631; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16402573, Lot Number 16402573; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16320650, Lot Number 16320650; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260430(10)15899340, Lot Number 15899340; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270819(10)16360511, Lot Number 16360511; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270630(10)16292003, Lot Number 16292003; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16205619, Lot Number 16205619; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270331(10)16191665, Lot Number 16191665; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270731(10)16300455, Lot Number 16300455; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270131(10)16075768, Lot Number 16075768; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16454763, Lot Number 16454763; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)270531(10)16379974, Lot Number 16379974; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260430(10)15878712, Lot Number 15878712; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260531(10)15797112, Lot Number 15797112; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260531(10)15832325, Lot Number 15832325; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260331(10)15796744, Lot Number 15796744; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, UDI (01)00827002349148(17)260831(10)15841288, Lot Number 15841288; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, UDI (01)00827002444317(17)261130(10)16256021, Lot Number 16256021; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, UDI (01)00827002444324(17)270131(10)16368587, Lot Number 16368587; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0048, UDI (01)00827002444324(17)260430(10)16056219, Lot Number 16056219.