Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook S...
FDA Device Recall #Z-2545-2021 — Class II — August 10, 2021
Recall Summary
| Recall Number | Z-2545-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 10, 2021 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | B. Braun Medical, Inc. |
| Location | Allentown, PA |
| Product Type | Devices |
| Quantity | 585,576 units |
Product Description
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 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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the country of Canada.
Lot / Code Information
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
Other Recalls from B. Braun Medical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1021-2025 | Class II | Design Options COMBINED SPINAL/EPIDURAL TRAY- ... | Dec 4, 2024 |
| Z-3144-2024 | Class II | AET36 ANESTH EXT SET - Anesthesia Extension Set... | Aug 8, 2024 |
| Z-2387-2024 | Class II | Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-U... | Jun 17, 2024 |
| Z-2380-2024 | Class II | Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE... | Jun 17, 2024 |
| Z-2391-2024 | Class II | Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE... | Jun 17, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.