Z-0106-2021Class II

Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and...

Name: Z-0106-2021 Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and...
Creator: Cook Inc.
Published: 2020-08-31
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2020-08-31 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail... on 2020-08-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0106-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Posted: 2020-10-14
Terminated: 2021-07-01
Recalling firm: Cook Incorporated
Product: Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock.
Product code: LJE Catheter, Nephrostomy
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
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
Quantity in commerce: 380
Distribution: Worldwide distribution - US Nationwide.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0106-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0105-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-14
Z-0106-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-21	2020-10-14

Product code LJE

K181735UnclassifiedPercutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent SetCook Incorporated / cleared 2019-03-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)