| Class 2 Device Recall Torcon NB Advantage | |
Date Initiated by Firm | October 21, 2019 |
Create Date | November 18, 2019 |
Recall Status1 |
Terminated 3 on June 30, 2020 |
Recall Number | Z-0449-2020 |
Recall Event ID |
84125 |
510(K)Number | K133130 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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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): HNB5.0-38-100-P-NS-HN5 REF (GPN): G07300 Lot Numbers: NS9700775, NS9705496, NS9710350, NS9713694 UDIs: (01)00827002073005(17)220511(10)NS9700775, (01)00827002073005(17)220509(10)NS9705496, (01)00827002073005(17)220515(10)NS9710350, (01)00827002073005(17)220514(10)NS9713694 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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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 | 98 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQO
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