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

FDA device recall Z-0979-2019 · posted 2019-03-13 · Terminated

Recall details

Recalling firm

Cook Inc.

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.

Action taken

Urgent Medical Device Recall notification letters were sent to customers on 2/1/19. Action to take 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com.

Root cause

Process control

Status

Terminated

Product code

DRC

Quantity 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.

Date initiated

2019-02-01

Date posted

2019-03-13

Date terminated

2020-06-30

Location

Bloomington, IN