Home / Recalls / Wilson-Cook Medical Inc. / Z-1745-2020

Z-1745-2020 Class II Terminated

Recalled by Wilson-Cook Medical Inc. — Winston Salem, NC

Recall Details

Product Type
Devices
Report Date
April 29, 2020
Initiation Date
February 4, 2020
Termination Date
January 15, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
89,423 devices total

Product Description

HEMO-7 Hemospray Endoscopic Hemostat

Reason for Recall

Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the carbon dioxide cartridge to exit the handle. Most of these complaints reported that the carbon dioxide cartridge exited the handle with minimal force. However, some complaints reported that the carbon dioxide cartridge exited the handle with the potential to project towards a user or a patient.

Distribution Pattern

Nationwide distribution. International distribution to Bahrain, Belarus, Canary Islands, Gibraltar, Guadeloupe, Guernsey, Iraq, Israel, Jersey, Jordan, Kuwait, Lebanon, Martinique, Monaco, Morocco, Oman, Pakistan, Qatar, Reunion, Saudi Arabia, Tunisia, United Arab Emirates, Unites States, Canada, Netherlands Antilles, Chile, Egypt, Japan, Mexico, Peru, Puerto Rico, Trinidad and Tobago, Australia, Brunei Dassalarum, Hong Kong, Korea, Myanmar, Macau, Malaysia, New Zealand, Philippines, Singapore, Thailand, Vietnam, Argentina, Brazil, Austria, Belgium, Bulgaria, Switzerland, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Iceland, Italy, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Croatia

Code Information

All Lot numbers manufactured 01/16/2017 - 01/15/2020 of both the following: HEMO-7 Order Number G56572 HEMO-10 Order Number G21049

Other recalls by Wilson-Cook Medical Inc.

  • Z-1362-2026 Class II — Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 U (December 18, 2025)
  • Z-1298-2026 Class II — Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 (December 15, 2025)
  • Z-0582-2025 Class II — Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, steril (October 31, 2024)
  • Z-0036-2025 Class II — Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; (August 29, 2024)
  • Z-0460-2024 Class II — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to (November 3, 2023)
  • Z-0457-2024 Class II — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to (November 3, 2023)
  • Z-0462-2024 Class II — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to (November 3, 2023)
  • Z-0458-2024 Class II — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used (November 3, 2023)
  • Z-0459-2024 Class II — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to (November 3, 2023)
  • Z-0461-2024 Class II — QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used t (November 3, 2023)