COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number... recall (Cook Incorporated)
Medical deviceClass IIOngoing
Summary: Cook Incorporated is recalling 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 Pa. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
What is being recalled
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.
Why
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1783-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 5, 2026 |
| Reported | April 15, 2026 |
| Company | Cook Incorporated |
| Company location | Bloomington, IN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1872 units |
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