FDA-Device2026-04-15Class IIMISBRANDING

Cook Medical Spectrum Central Venous Catheter Tray recalled for incorrect expiration dates

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

Cook Medical issued a recall of certain Spectrum Central Venous Catheter Tray units because the labels show expiration dates that are longer than the actual shelf life of the product. This means some trays labeled as usable may have actually expired. No injuries have been reported.

  • Check the lot number on any Cook Spectrum Central Venous Catheter Tray in your facility against the FDA recall list
  • Do not use affected trays beyond their true expiration date
  • Contact Cook Medical or your supplier for replacement trays or instructions
  • Report any use of recalled product to Cook Medical immediately
The agency's original wording
Hazard

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution.
Affected count
1872 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1783-2026

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