Recall Z-2553-2025 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Merit Medical Systems, Inc.
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices.
| Date | Sep 11, 2025 (initiated Jul 25, 2025) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. |
| Root cause | Employee error |
| Action | On 07/23/2025, the firm emailed an "URGENT MEDICAL DEVICE RECALL NOTICE" to customers informing them that due to a manufacturing defect. Specifically, the o-ring between the y-body and the rotator may be damaged during assembly and a portion of the o-ring may remain loose or detach. Use of the affected product may result in a foreign body in the fluid path. Customer are instructed to: Immediately stop using or distributing the affected lots and return to Merit. 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within your facilit |
| Quantity | 447 |
| Distribution | Worldwide - U.S. Nationwide distribution in the states of CA, FL, LA, MT, NY, SD, and WI. The countries of Canada and Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.