Cook Transseptal Needle recall
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional…
Why was Cook Transseptal Needle recalled?
The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
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?
Lot 8833687
- Product
- Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional…
- Recalling firm
- Cook Inc.
- Quantity
- 100
- Distribution
- US nationwide and Canada. US distribution to the following states: AZ, FL, IL, IN, KS, MA, MI, MO, PA, SC, TN, and WA. The products were distributed to the following foreign countries: Canada.
- Recall date
- March 20, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)