Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Reported: March 20, 2019 Initiated: February 1, 2019 #Z-0979-2019
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.. Recalled by Cook Inc.. Units affected: 100.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 20, 2019. Severity: Critical. Recall number: Z-0979-2019.
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