Cook Inc. Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa

Recommended Action

Per FDA guidance

Cook Medical issued Urgent Medical Device Recall letters via mail and/or email to consignees globally. Letter states reason for recall, health risk and action to take: 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 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 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 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

Distribution

As reported by FDA

AL, AZ, CA, DE, FL, GA, KS, MI, MN, MO, NY, NC, OK, TX