Advance¿ 35LP Low-Profile PTA Balloon Dilatation recall: Labeling Error
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…
Why was Advance¿ 35LP Low-Profile PTA Balloon Dilatation recalled?
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog number: PTA5-35-135-6-2 .0 lot 8429883; Catalog number: PTA5-35-135-4-4.0 lot 8426883
- 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…
- Recalling firm
- Cook Inc.
- Quantity
- 40 total products
- Distribution
- Worldwide Distribution - US Nationwide in the states of AZ, DE, FL, GA, ID, IL, KY, MI, MO, NH, NJ, PA, RI, TX, UT and the country of Peru
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)