Recall Z-0036-2025 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Wilson-Cook Medical Inc.
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.
| Date | Oct 16, 2024 (initiated Aug 29, 2024) |
| Status | Open, Classified |
| Reason | Specific lots of product have been manufactured with nonconforming raw materials. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | UPDATE-4,605 devices |
| Distribution | Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Costa Rica, and Guatemala. UPDATE 1/30/2025: Foreign distribution was made to: Australia, Austria, Belgium, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200972 | Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc., Jun 10, 2020 |