Cook Medical Hemospray Hemostat (Wilson-Cook) – activation knob defect (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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