| Class 2 Device Recall | |
Date Initiated by Firm | November 12, 2021 |
Create Date | December 16, 2021 |
Recall Status1 |
Terminated 3 on April 26, 2024 |
Recall Number | Z-0388-2022 |
Recall Event ID |
89072 |
510(K)Number | K142829 |
Product Classification |
Introducer, catheter - Product Code DYB
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Product | Flexor Check-Flo Introducer Ansel Modification
Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC
Order Number/GPN: G44155
Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. |
Code Information |
Lot Number: 13911710
UDI: (01)00827002441552(17)240422(10)13911710
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Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact | SAME 812-339-2235 |
Manufacturer Reason for Recall | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa |
FDA Determined Cause 2 | Process control |
Action | 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. |
Quantity in Commerce | 47 units |
Distribution | AL, AZ, CA, FL, GA, KS, MI, MO, MN, NC, NY, OK, TX
Foreign:
BE, CH, DE, ES, FR, GB,GU, IT, ZA
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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 = DYB
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