Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Incorrect Expiration Dates
Cook Inc. is recalling 25 Spectrum Central Venous Catheter Trays because the printed expiration dates are incorrect. The devices were distributed to seven US states and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is incorrect printed expiration dates and does not report any illnesses or injuries. This aligns with the rubric for minor labeling errors or voluntary precautionary recalls where the hazard is theoretical.
Plain-English summary
Cook Inc. is voluntarily recalling 25 units of the Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053. The recall is being conducted because the printed expiration dates on the products are incorrect.
The affected products were distributed to the following US states: Colorado, Delaware, Maryland, Minnesota, North Carolina, Nevada, and West Virginia. The products were also distributed to Canada. The specific lot number is 10235662, and the UDI is (01)00827002480537(17)562310(10)10235662.
This is an FDA Class II recall. No illnesses or injuries have been reported in connection with this recall. Healthcare facilities and consumers should check their inventory for the specific lot number and order number listed above. If the product is found, it should be removed from use and returned to Cook Inc. or the distributor.
The recalled product
- Product
- Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 10235662
- UDI: (01)00827002480537(17)562310(10)10235662
Distribution
Part of a larger recall action
This product is one of 2 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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