Recall Z-0036-2025— Wilson-Cook Medical Inc.

Name: FDA recall Z-0036-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-29

Class II · Ongoing

Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2024-08-29. It names one FDA 510(k) clearance: K200972. Product: Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.. Reason: Specific lots of product have been manufactured with nonconforming raw materials..

Recalling firm: Wilson-Cook Medical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-29
Firm location: Winston Salem, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K200972 — Hemospray Endoscopic HemostatWilson-Cook Medical, Inc.·cleared 2020-06-10

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 Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

Reason for recall

Specific lots of product have been manufactured with nonconforming raw materials.

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