FDA recall Z-0979-2019

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 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.

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.

Key facts

Status

Terminated

Initiation date

2019-02-01

Report date

2019-03-20

Termination date

2020-06-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0979-2019