Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1370-2019 — 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

U.S. FDA — Device Enforcement · United States · 2019-04-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1370-2019
Date of alert
2019-04-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Inc.
Product category
device
Product type
Devices
Reported risk: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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