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U.S. Department of Health and Human Services

Class 2 Device Recall Skinny Needle with Chiba Tip

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  Class 2 Device Recall Skinny Needle with Chiba Tip see related information
Date Initiated by Firm October 13, 2021
Create Date December 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-0414-2022
Recall Event ID 89104
Product Classification Catheter, nephrostomy - Product Code LJE
Product Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290.

Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment.
Code Information RPN 090010/GPN G14254: LOT NUMBER UDI 13977925 (01)00827002142541(17)240524(10)13977925 14030949 (01)00827002142541(17)240617(10)14030949 14054162 (01)00827002142541(17)240628(10)14054162 14116047 (01)00827002142541(17)240728(10)14116047 RPN 090010-ET/GPN G15290: LOT NUMBER UDI 14038615 (01)00827002152901(17)240618(10)14038615
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
812-339-2235
Manufacturer Reason
for Recall		 Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.
FDA Determined
Cause 2		 Process change control
Action On October 13, 2021, the firm distributed Urgent Medical Device Recall letters to customers. Customers were informed that the needles may contain black debris on the exterior of the inner stylet and/or the interior of the outer cannula. Potential adverse events that may occur if an affected product is used include local/self-limited inflammatory reactions. To date, Cook has received no complaints related to this issue. However, please be advised that the presence of black debris may go undetected by the user. Actions to be Taken by the Customer 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 these products. 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. 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. Action being Taken by Cook Medical Cook Medical is removing potentially impacted devices from the market. Additionally, an investigation has been opened to determine the appropriate corrective action(s) to prevent reoccurrence of a similar issue. If you have any questions or concerns, please contact Cook Medi
Quantity in Commerce 112 US, 240 OUS
Distribution Worldwide distribution - US Nationwide distribution in the states of AL, CA, IN, LA, MS, MT, NC, NY, OR, PA, WA and the countries of France, Italy, and Mexico.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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