Cook Inc. recalls Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both…

Recall date

February 1, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0979-2019

FDA classification

Class I

Brand / firm

Cook Inc.

Sold / distributed

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.

Why it was 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What 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.