Class 2 Device Recall COOK Hemospray Endoscopic Hemostat

• Date Initiated by Firm: February 04, 2020
• Create Date: April 17, 2020
• Recall Status: Terminated on January 15, 2021
• Recall Number: Z-1745-2020
• Recall Event ID: 84822
• Product Classification: Hemostatic device for endoscopic gastrointestinal use - Product Code QAU
• Product: HEMO-7 Hemospray Endoscopic Hemostat
• 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
• FEI Number: 1037905
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc.; 4900 Bethania Station Rd; Winston Salem NC 27105-1203
• For Additional Information Contact: 336-744-0157
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: Cook Medical notified customers initially via "URGENT: MEDICAL DEVICE RECALL" letters sent on about 02/04/2020 and 02/25/2020. The letters contained the same information and informed customers that Cook Medical has received complaints that the handle and/or activation knob on Hemospray Endoscopic 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. Instructions to customers included to examine inventory for affected devices, cease use of them and quarantine them, return affected devices immediately to Cook Medical, and complete and return the Acknowledgement and Receipt Form. Additionally customers were instructed to inform appropriate personnel and customers, if further distributed, of the recall down to the user level. Questions or concerns can be directed to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
• Quantity in Commerce: 89,423 devices total
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.