Recall Z-2632-2017 ยท KZD Infusor, Pressure, For I.V. Bags
3M Company - Health Care Business
3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
| Date | May 22, 2017 |
| Status | Terminated |
| Reason | It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification. |
| Root cause | Process control |
| Action | The firm, 3M, sent a letter dated 5/22/2017, to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee was informed that there is no safety issue; however, the firm will be replacing unit. In addition, a representative from 3M will be visiting the facility and exchanging the product for a new one. Please feel free to call (713) 292-4430 or email baprestera@mmm.com if you have any questions. |
| Quantity | 1 unit |
| Distribution | U.S. Distribution: TX only |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.