Z-0414-2022Class II

Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip...

Name: Z-0414-2022 Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip...
Creator: Cook Inc.
Published: 2021-10-13
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2021-10-13 / Open, Classified

FDA source

Cook Inc. began a recall of Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip... on 2021-10-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0414-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-13
Posted: 2021-12-22
Recalling firm: Cook Incorporated
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.
Product code: LJE Catheter, Nephrostomy
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 root cause: 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 ([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
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0414-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0414-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-29	2021-12-22

Product code LJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)