CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report
Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled
Cook is recalling Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference. The recall was initiated on 5 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1783-2026
- FDA event ID
- 98495
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Mar 2026
- FDA classified
- 6 Apr 2026
- Reported
- 15 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 5 Mar 2026 | Recall initiated by company | |
| 6 Apr 2026 | Classified by FDA | +32 days |
| 15 Apr 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Which lots are 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.
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 98495This product is part of a recall event; the main page for the event is Medical Arterial Pressure Monitoring Tray, Reference recalled.
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