Recall Z-0979-2019— Cook Inc.
Class I · Terminated
Class I FDA medical device recall by Cook Inc., initiated 2019-02-01, terminated 2020-06-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.. Reason: 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..
- Recalling firm
- Cook Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-02-01
- Terminated
- 2020-06-30
- Firm location
- Bloomington, IN, United States
Product description
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.