Class 2 Device Recall Cook Medical HEMO7EU

• Date Initiated by Firm: October 31, 2024
• Date Posted: December 02, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0582-2025
• Recall Event ID: 95755
• Product Classification: Hemostatic device for endoscopic gastrointestinal use - Product Code QAU
• Product: Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
• Code Information: UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.
• FEI Number: 1037905
• Recalling Firm/ Manufacturer: Wilson-Cook Medical Inc.; 4900 Bethania Station Rd; Winston Salem NC 27105-1203
• For Additional Information Contact: Cook Medical Customer Relations; 800-457-4500
• Manufacturer Reason for Recall: Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The recalling firm issued letters on 10/31/2024 dated 11/1/2024 via email to their consignees extending the voluntary recall from 29 August 2024 to include additional lot numbers of Hemospray Endoscopic Hemostat devices due to the receipt of additional complaints and adverse events since the recall was originally initiated. The consignee was instructed to review the attached list to ensure that affected devices are quarantined and returned to the recalling firm. The letter goes onto discuss the indications for use for the 2 previously recalled devices (HEMO-7 and HEMO-10) and provides the indications for use for the HEMO-7-EU device, which were different from the HEMO-7 and HEMO-10 devices. The reason for recall was explained, the risk to health, and specific product identification and device information (device brand name, reference part number, model number, and UDI-DI number). The actions to be taken by the customer were provided, which included immediately examining inventory and quarantining affected devices, return of the devices, completing the Acknowledgement and Receipt Form within 5 business days of receiving the letter, sharing the notice with appropriate personnel, including down to the user level with or outside their organization to anywhere the devices were transferred, and immediately reporting adverse events to Cook Medical Customer Relations. Actions to be taken by the distributor included the same details as for the customer except that the distributor was to notify any organizations that have been distributed the devices. On 11/20/2024, the firm provided a copy of the recall letter for the HEMO-7-EU dated 11/20/2024 they issued via email to their consignees. The letter explained the HEMO-7-EU was identified as also needing to be recalled when the firm expanded their recall of HEMO-7 and HEMO-10. The letter provided the reason for recall, risk to health, product identification and device information, and actions to be taken by the distri
• Quantity in Commerce: 46 devices
• Distribution: Distribution was OUS only to Argentina, Brazil, and Israel.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.