Z-0428-2020Class II
Torcon NB Advantage Catheters -
Cook Incorporated / initiated 2019-10-21 / Terminated / root cause: packaging
Cook Inc. began a recall of Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic... on . FDA classified it as Class II and gives the reason as "The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0428-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Cook Incorporated
- 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.
- Product code
- DQO Catheter, Intravascular, Diagnostic
- Reason for recall
- The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
- Root cause tag
- packaging
- FDA root cause
- 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 ([email protected]). 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: [email protected]. 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
- 90
- 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.
- Product codes and lots
- REF (RPN): HNB5.0-38-100-P-NS-JL4 REF (GPN): G05923 Lot Numbers: 9700383, NS9701376 UDIs: (01)00827002059238(17)220510(10)9700383, (01)00827002059238(17)220508(10)NS9701376
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0421-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0422-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0423-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0424-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0425-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0426-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0427-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0428-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0429-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0430-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0431-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0432-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0433-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0434-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0435-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0436-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0437-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0438-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0439-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0440-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0441-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0442-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0443-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0444-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0445-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0446-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0447-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0448-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0449-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0450-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0451-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0452-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0453-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0454-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0455-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0456-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0457-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0458-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0459-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0460-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0461-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0462-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0463-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0464-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0465-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0466-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0467-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0468-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0469-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0470-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0471-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0472-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0473-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0474-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0475-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0476-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0477-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0478-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0479-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0480-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0481-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0482-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0483-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0484-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0485-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0486-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0487-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0488-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0489-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0490-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0491-2020 | Class II | Terminated | Voluntary: Firm initiated |
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