Cook Transseptal Needle Recalled for Missing Back Bevel
Cook Inc. is recalling 100 units of Transseptal Needles manufactured without a back bevel on the needle tip, which could damage the introducer during insertion.
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 I, which typically indicates a low risk of adverse health consequences. The hazard involves potential equipment damage rather than direct patient injury, fitting the criteria for a moderate severity score.
Plain-English summary
Cook Inc. is recalling 100 units of the Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364, Lot 8833687. These medical devices are used for transseptal left heart access in both diagnostic and interventional procedures.
The recall was initiated because the products were manufactured without a back bevel on the needle tip. According to the source, this defect could cause damage to the inside of the introducer during needle insertion.
The affected products were distributed nationwide in the United States and in Canada. In the US, distribution was limited to Arizona, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Missouri, Pennsylvania, South Carolina, Tennessee, and Washington. Consumers and healthcare providers should stop using the affected needles and contact Cook Inc. for further instructions.
The recalled product
- Product
- Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 100
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 8833687
Distribution
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