Reported Mar 20, 2019 · Terminated
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both…
Cook Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
- Lot codes and dates
- Lot 8833687
- Amount recalled
- 100
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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