—#172724

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

FDA product code: KOB — Catheter, Suprapubic (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K810368
Affected lot / code info: All lot codes

Why it was recalled

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 (FDA determination)

Error in labeling

Action the firm took

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

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-04-22
Terminated: 2020-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172724. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.