Terumo Cardiovascular Procedure Kit Recalled for Undeclared Natural Rubber Latex
Terumo Cardiovascular Systems Corporation is recalling 12 packs of Cardiovascular Procedure Kits because the presence of natural rubber latex is not declared on the label.
What this means for you
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 and involves a labeling error regarding a common allergen (natural rubber latex). Per the rubric, minor labeling errors and low-risk contamination issues are typically rated as Moderate (2), especially when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 12 packs of Cardiovascular Procedure Kits (CLR MP4 COIL 2 SPIKE), Catalog Number 140222. The recall is due to a labeling error where the presence of natural rubber latex is not declared on the product label.
The affected products are identified by Lot Number V A30. The recall is limited to distribution in Texas (TX). This labeling omission poses a risk to individuals with latex allergies who may be exposed to the material during use.
Healthcare facilities and consumers who have these specific kits should stop using them and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 12
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 (1)
- Lot Numbers: V A30
Distribution
Distributed in 1 state:
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