Cook Inc. Recalls Advance 35LP Balloon Catheters Due to Labeling Error
Cook Inc. is recalling 40 Advance 35LP Low-Profile PTA Balloon Dilatation Catheters because some units were packaged with incorrect size labels.
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 and involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cook Inc. is recalling 40 units of the Advance 35LP Low-Profile PTA Balloon Dilatation Catheter. The recall involves catalog numbers PTA5-35-135-6-2.0 (lot 8429883) and PTA5-35-135-4-4.0 (lot 8426883). The FDA has classified this as a Class II recall.
The reason for the recall is incorrect product labeling. Specifically, products labeled as 6mm x 2cm balloons were packaged with a 4mm x 4cm balloon label, and vice versa. This labeling discrepancy could lead to the use of the wrong device size during percutaneous transluminal angioplasty procedures.
The affected products were distributed worldwide, including nationwide in the United States in the states of Arizona, Delaware, Florida, Georgia, Idaho, Illinois, Kentucky, Michigan, Missouri, New Hampshire, New Jersey, Pennsylvania, Rhode Island, Texas, and Utah, as well as in Peru. Healthcare providers and facilities should stop using the affected lots and contact Cook Inc. for instructions on return or replacement.
The recalled product
- Product
- Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous…
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 40
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)
- Catalog number: PTA5-35-135-6-2 .0 lot 8429883
- Catalog number: PTA5-35-135-4-4.0 lot 8426883
Distribution
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