OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the… — Class II medical device recall Z-2552-2021
Terminated recall by B. Braun Medical, Inc., reported 2021-10-06, distributed nationwide. Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration o
| Recall number | Z-2552-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2021-08-10 |
| Classified | 2021-09-24 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2024-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 12,216 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04046964857263 |
| Lot numbers | 0061755664, 0061757771, 0061757873, 0061763933, 0061768487, 0061786789 |
| Model numbers | 474004 |
Product
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2552-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.