FDA Device recall Z-2544-2021
15 drops/ml, Priming Volume: 27ml, Length: 129 in
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of 15 drops/ml, Priming Volume: 27ml, Length: 129 in by B Braun Medical, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2544-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-10 |
| Published | 2021-10-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Lot Code: 0061752459 0061752460 0061755100 0061755637 0061757837 0061757838 0061758588 0061759428 0061759475 0061761605…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2544-2021%22
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