Recall Z-1370-2019— Cook Inc.

Name: FDA recall Z-1370-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-22

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2019-04-22, terminated 2020-05-05. It names one FDA 510(k) clearance: K810368. 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. Reason: Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-04-22
Terminated: 2020-05-05
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K810368 — VANCE PERCUTANEOUS MALECOT NEPHROSTOMYVance Products, Inc.·cleared 1981-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.