FDA Device recall Z-2545-2021
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT P…
- FDA Device
- Class II
- terminated
- Published 2021-10-06
On 2021-10-06 the FDA classified a Class II recall of Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT P… 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-2545-2021 |
| 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
Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413
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: 0061755638 0061757839 0061759426 0061763839 0061763893 0061763894 0061766190 0061767014 0061767027 0061768466…Lot Code: 0061755638 0061757839 0061759426 0061763839 0061763893 0061763894 0061766190 0061767014 0061767027 0061768466 0061769094 0061772192 0061772193 0061775455 0061776025 0061776298 0061776299 0061776300 0061776301 0061777154 00VL752555 00VL754131 DI: 04046964182211 |
|---|
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-2545-2021%22
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