Recall Z-0533-2026 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Merit Medical Systems, Inc.
PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
| Date | Nov 17, 2025 (initiated Aug 4, 2025) |
| Status | Open, Classified |
| Reason | Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage. |
| Root cause | Process change control |
| Action | On 8/4/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Identify affected devices, quarantine, discontinue use, and distribution. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. Additional distribution details may be required by health authorities. 4) Complete and return the cu |
| Quantity | 217,141 |
| Distribution | US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS, NJ, MI, VA, KY, AL, MT, NE, MA, MO, TN, CT, MD, WA, DC, ME, OR, NH, IN, GA, UT, OK, HI, RI, ID, NM, MS, WV, SD, DE, NV, ND. OUS: United Arab Emirates, Australia, Italy, Spain, Sweden, Norway, Germany, France, Belgium, Nethe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.