Recall Z-0582-2025 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Wilson-Cook Medical Inc.
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
| Date | Dec 2, 2024 (initiated Oct 31, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 in |
| Quantity | 46 devices |
| Distribution | Distribution was OUS only to Argentina, Brazil, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.