CLASS II Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

Outlook Pump Set, 3 Caresite Lads-single use, for use recalled

B. Braun Medical is recalling Outlook Pump Set, 3 Caresite Lads-single use, for use with the Outlook Safety Infusion, 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

Lot, batch or date codesLot Code: 0061757775 0061765083 0061777822 DI: 04046964642623

Quantity recalled7,248 units

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-2556-2021
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: Other Medical Devices

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 SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361

Where it was distributed

Worldwide distribution - US Nationwide distribution and the country of Canada.

Nationwide

Questions about this recall

Is Outlook Pump Set, 3 Caresite Lads-single use, for use with the Outlook Safety Infusion recalled?

Yes. B. Braun Medical recalled Outlook Pump Set, 3 Caresite Lads-single use, for use with the Outlook Safety Infusion on 10 Aug 2021. The recall is Class II and its status is Terminated. Recall number Z-2556-2021.

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: 0061757775 0061765083 0061777822 DI: 04046964642623

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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