Merit Medical Systems, Inc. Recall 95343
Description: basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Merit Medical Systems, Inc. Recall 95343 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0072-2025 |
| Event ID | 95343 |
| Event Description | basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C |
| Product Type | Devices |
| 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, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan. |
| Quantity | 16,439 |
| Recall 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. |
| Device Classification | 20241023 |
| Device Code Info | REF/UDI-DI/Lot(Expiration): IN8130/JPC/00884450621073/H2929530(4/29/2027). IN8152/C/00884450621301/H2925219(4/22/2027), H2929412(4/29/2027), H2938005(5/12/2027), H2938006(5/12/2027), H2943498(5/19/2027), H2943499(5/19/2027), H2972593(5/26/2027), H2972594(5/26/2027), H2978092(6/3/2027). IN8302/C/00884450621325/H2925221(4/22/2027). IN8352/C/00884450621349/H2934719(5/5/2027). IN8802/C/00884450621417/H2925222(4/22/2027), H2934720(5/12/2027), H2943517(5/19/2027), H2972598(5/26/2027). IN8130/C/00884450621059/H2925215(4/22/2027), H2929410(4/29/2027), H2934714(5/5/2027), H2937998(5/12/2027), H2938000(5/12/2027), H2943487(5/19/2027). IN8130/C/00884450621059/H2972590(5/26/2027), H2978089(6/3/2027), H2978090(6/3/2027), H2978091(6/3/2027), H2989571(6/17/2027). |
| Center Classification Date | 20241011 |
| Recall Initiation Date | 20240819 |
| Recalling Firm | Merit Medical Systems, Inc. |
| Initial Notification | Letter |
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