FDA Recall Terminated

Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm radiopaque dilator; a 6 French, 7 cm radiopaque pigtail catheter; a retention disc with pull tie; and a 10 French, 10 cm clear, polyvinylchloride connecting tube with one-way stopcock.

Recall: Z-0105-2021 · Initiated August 31, 2020

Recall

Recall Number: Z-0105-2021
Event Number: 86411
Firm: Cook Inc.
FEI Number: 1820334
Product Code: LJE
Status: Terminated
Root Cause: No Marketing Application
Initiated: August 31, 2020
Terminated: July 1, 2021
Address: 750 N Daniels Way, Bloomington, IN, 47404-9120

Description

Reason

The indwell time for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set is decreasing from 4 months to 4 weeks. The current IFU is in process of being updated and will be provided with orders placed following implementation.

Action

URGENT: MEDICAL DEVICE CORRECTION notification letters dated 8/31/20 were sent to customers. Actions to be Taken by the Customer 1. If affected products have already been placed within a patient, the indwell time should not exceed 4 weeks. If the current indwell time has exceeded 4 weeks, consider removing and/or replacing the product. 2. Understand that if an affected product is placed within a patient longer than 4 weeks, there is an increased potential for breakage, kinking, encrustation, migration, and/or infection to occur. 3. Please maintain a copy of this notice with the current IFU or product(s) in your inventory. 4. If you have affected product in inventory, you may continue to use these products. Cook Medical is not requesting product be returned. 5. 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]). 6. 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. 7. 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 initiating a voluntary correction to inform customers that the indicated indwell time is changing for the Percutaneous Neonatal Pigtail Nephrostomy Set and Pediatric Nephrostomy Stent Set. The current IFU is in process of being updated and will be provided with orders placed following implementation. We recognize that this situation is a potential disruption to your normal operations, and we sincerely apologize. Thank you for your

Distribution

Worldwide distribution - US Nationwide.

Quantity

368