B. Braun Medical, Inc. Recall 88531
Description: 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
B. Braun Medical, Inc. Recall 88531 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2544-2021 |
| Event ID | 88531 |
| Event Description | 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Canada. |
| Quantity | 978,876 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: 0061752459 0061752460 0061755100 0061755637 0061757837 0061757838 0061758588 0061759428 0061759475 0061761605 0061765911 0061766189 0061767026 0061767841 0061769047 0061769091 0061769931 0061770185 0061770486 0061771274 0061772190 0061775452 0061776078 0061776101 0061776773 0061776915 0061777160 0061777161 0061780362 Lot Codes: 0061780840 0061781779 00VL752554 DI: 04046964293832 |
| Center Classification Date | 20210924 |
| Recall Initiation Date | 20210810 |
| Recalling Firm | B. Braun Medical, Inc. |
| Initial Notification | Letter |
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