Recall Z-2293-2025 ยท FPK Tubing, Fluid Delivery
Merit Medical Systems, Inc.
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
| Date | Aug 12, 2025 (initiated Jun 5, 2025) |
| Status | Open, Classified |
| Reason | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. |
| Root cause | Process control |
| Action | On 5/5/2025, recall notices were emailed to customers who were asked to do the following: 1) Identify affected devices and quarantine, discontinue use and distribution. 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. 4. Return all affected devices to the firm. 5. Complete, and return the customer response form via email to respo |
| Quantity | 8040 |
| Distribution | US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883718 | MERIT HI-FLEX(TM) Merit Medical Systems, Inc., Jan 30, 1989 |