Recall Z-1978-2023— Wilson-Cook Medical Inc.

Name: FDA recall Z-1978-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-22

Class II · Ongoing

Class II FDA medical device recall by Wilson-Cook Medical Inc., initiated 2023-05-22. It names one FDA 510(k) clearance: K200972. Product: Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;. Reason: There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope..

Recalling firm: Wilson-Cook Medical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-22
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

Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;

Reason for recall

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

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