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U.S. Department of Health and Human Services

Class 2 Device Recall Torcon NB Advantage

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  Class 2 Device Recall Torcon NB Advantage see related information
Date Initiated by Firm October 21, 2019
Create Date November 18, 2019
Recall Status1 Terminated 3 on June 30, 2020
Recall Number Z-0463-2020
Recall Event ID 84125
510(K)Number K133130  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
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.
Code Information REF (RPN): HNB5.0-38-80-P-NS-HS2 REF (GPN): G10598 Lot Numbers: NS9904742, NS9906243, NS9906244, NS9914968, NS9914970, NS9928941, NS9943480, NS9943481 UDIs: (01)00827002105980(17)220731(10)NS9904742, (01)00827002105980(17)220731(10)NS9906243, (01)00827002105980(17)220801(10)NS9906244, (01)00827002105980(17)220805(10)NS9914968, (01)00827002105980(17)220805(10)NS9914970, (01)00827002105980(17)220809(10)NS9928941, (01)00827002105980(17)220826(10)NS9943480, (01)00827002105980(17)220822(10)NS9943481
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
812-339-7361
Manufacturer Reason
for Recall		 The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
FDA Determined
Cause 2		 Process change control
Action 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.
Quantity in Commerce 45
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = COOK, INC.
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