Skinny Needle with Chiba Tip. RPN 090010, 090010-ET recallZ-0414-2022 · Cook Inc. · initiated Oct 13, 2021

Why it was recalled

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 root cause category: Process change control

What the company is doing

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 ([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]. 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

Recall details

Recall number

Z-0414-2022

Status

Open, Classified

Initiated by the company

Oct 13, 2021

Recalling firm

Cook Inc.

Quantity

112 US, 240 OUS

Product code

LJE

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.

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Cook G14254

  Cook Incorporated · CATHETER, NEPHROSTOMY
  1 recall0 reports