—#177362

Product

Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K133130
Affected lot / code info: REF (RPN): HNB5.0-38-100-P-NS-AR2 REF (GPN): G10748 Lot Number: 9714133 UDI: (01)00827002107489(17)220516(10)9714133

Why it was recalled

The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.

Root cause (FDA determination)

Process change control

Action the firm took

On October 21, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail instructing them to: 1. Examine inventory immediately to determine if you have affected product(s), and quarantine affected product(s). 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. 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. Adverse events or quality problems experienced with the use of this product may also be reported to the FDA: " Visit http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm to obtain a form to fax or mail. " Call the FDA at 800.FDA.1088. We recognize that this situation is a potential disruption to your normal operations, and we sincerely apologize. Thank you for your immediate assistance in this matter. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. We look forward to your response.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, LA, MA, MD, Ml, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and PR. Countries of AU, BE, CA, CN, CZ, DK, FR, DE, GT, HK, IT, KR, LU, MX, NL, PK, PL, ZA, ES, SE, CH, TW, and GB.

Timeline

Recall initiated: 2019-10-21
Terminated: 2020-06-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177362. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.