CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report
Outlook Pump Sets w/3 Caresite Needle-Free Injection Sites recalled
B. Braun Medical is recalling Outlook Pump Sets w/3 Caresite Needle-Free Injection Sites: single-use for use with the, distributed nationwide in the US. The recall was initiated on 10 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2545-2021
- FDA event ID
- 88531
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2021
- FDA classified
- 24 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Syringes & Needles
Timeline
| 10 Aug 2021 | Recall initiated by company | |
| 24 Sep 2021 | Classified by FDA | +45 days |
| 6 Oct 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide distribution and the country of Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide distribution and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 88531This product is part of a recall event; the main page for the event is PUMP SET, 15 DR, 3 CARESITEsingle-use for use recalled.
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|---|---|---|---|---|---|
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | Nationwide |
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| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |