B. Braun Medical, Inc. Recall 88531
Description: 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
B. Braun Medical, Inc. Recall 88531 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2548-2021 |
| Event ID | 88531 |
| Event Description | 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Canada. |
| Quantity | 55,584 units |
| Recall Reason | Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections. |
| Device Classification | 20211006 |
| Device Code Info | Lot Code: 0061760493 0061763906 0061764288 0061765128 0061771281 DI: 04046964182273 |
| Center Classification Date | 20210924 |
| Recall Initiation Date | 20210810 |
| Recalling Firm | B. Braun Medical, Inc. |
| Initial Notification | Letter |
| Similar To |