Recall Z-0068-2025 ยท PTM Syringe, Balloon Inflation, Exempt
Merit Medical Systems, Inc.
BlueFIRE Inflation Device, REF: IN10140
| Date | Oct 11, 2024 (initiated Aug 19, 2024) |
| Status | Open, Classified |
| Reason | Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection. |
| Root cause | Packaging process control |
| Action | On 8/19/24, recall notices were emailed to customers asking them to do the following: 1) If affected devices are discovered, quarantine them, discontinue use and distribution, and return to the recalling firm. 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. 4) Complete and return the customer response form via email to respo |
| Quantity | 5 |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaic |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.