Z-1370-2019Class II

Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168...

Name: Z-1370-2019 Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168...
Creator: Cook Inc.
Published: 2019-04-22
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-04-22 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr... on 2019-04-22. FDA classified it as Class II and gives the reason as "Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting". 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-1370-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-22
Posted: 2019-05-17
Terminated: 2020-05-05
Recalling firm: Cook Incorporated
Product: Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
Product code: KOB Catheter, Suprapubic (And Accessories)
Reason for recall: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Cook issued MEDICAL DEVICE CORRECTION letters via courier to US Consignees on April 22, 2019. The letter provides reason for recall, products affected, health risk, action to take: Understand that stent knotting is a potential complication associated with use of the Kwart Retro-Inject" Stent Set and Salle Intraoperative Pyeloplasty Stent Set and should be considered if significant resistance is encountered during attempts at removal. 2. Please maintain a copy of this notice with the current IFU or product(s) in your inventory. 3. If you have affected product in inventory, you may continue to use these products. Cook Medical is not requesting product be returned. 4. Complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter.5. 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 products have been transferred. Questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Quantity in commerce: 3711
Distribution: Nationwide Foreign: Australia Canada Austria Belgium Denmark Germany Spain Finland France Martinique French Polynesia Switzerland Ireland Italy Netherlands Poland Sweden United Kingdom Hong Kong New Zealand Chile Colombia Israel Russian Federation Czech Republic Greece Jordan Slovakia South Africa United Arab Emirates Slovenia Lithuania Morocco Romania Qatar Bulgaria Libya Saudi Arabia Turkey Ukraine Thailand
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1370-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1369-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-17
Z-1370-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-17

Product code KOB

K810368Class IIVance Percutaneous Malecot NephrostomyVance Products, Inc. / cleared 1981-03-20

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)