Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

Specific lots of product have been manufactured with nonconforming raw materials.

The recalling firm issued letters on and dated 8/29/2024 via FedEx to U.S. customers and via email to OUS customers. The letter explained the reason for recall, risk to health, product identification and device information, and the actions to be taken by the customer. The actions included: (1) Examine inventory immediately to determine if you have affected device(s) and quarantine affected device(s). Immediately cease all use of the affected devices; (2) Return the affected device(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a credit; (3) Complete and return the Acknowledgement and Receipt Form within 5 business days of receiving the letter even if you do not have the affected devices on hand; (4) Share the notice with the appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred; and (5) Immediately report adverse events to Cook Medical Customer Relations by phone or email. The actions to be taken by the distributor include the same actions as provided for the customer except the distributor was instructed to immediately cease all distribution of the affected devices. UPDATE PER 10/25/2024 email: The recalling firm expanded their recall to include additional lot numbers as a result of receiving reports of additional complaints and adverse events. The firm issued letters on and dated 11/1/2024 via FedEx and email to only consignees who received the expanded lot numbers. The letter made reference to the original recall of 8/29/2024 and contained similar details to that letter. UPDATE PER 1/20/2025 EMAIL: The recalling firm issued letters dated 29-October-2024 on 1/10/2025 to an additional 8 OUS consignees as a result of some on-hold inventory being inadvertently distributed. Included with the letter to the 8 OUS customers was a specifically tailored short list (spreadsheet) of the lot numbers they purchased.