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

Y-Type Blood, Outlook Pump Set, Caresite-single-use recalled

B. Braun Medical is recalling Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety, 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: 0061772234 DI: 04046955202799

Quantity recalled1,752 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-2553-2021
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

Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005

Where it was distributed

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

Nationwide

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: 0061772234 DI: 04046955202799

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 88531

This product is part of a recall event; the main page for the event is PUMP SET, 15 DR, 3 CARESITEsingle-use for use recalled.

Reported	Class	Recall	Company	Reason	Where
6 Oct 2021	CLASS II	PUMP SET, 15 DR, 3 CARESITEsingle-use for use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	15 drops/ml, Priming Volume:, Length: Single-use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump Primary Administration Set w/ micro Tubing for Epidural recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump Set 3 Caresite Lads-single use, for use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump IV Set W/Universal Spike-single-use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	60 drops/ml, Priming volume:, Length:in-single-use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump Blood Administration Set recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	ET82HP Outlook Pump Extension Set-single-use for use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	10 drops/ml, Priming volume:, Length:-single-use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	V1500HP Outlook Pump Set 118-single-use for use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump IV Set-single-use for use recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump Add-On Set-single use, for use recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump Set, 3 Caresite Lads-single use, for use recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set recalled	B. Braun Medical	Packaging Defects	Nationwide
6 Oct 2021	CLASS II	Outlook Pump Sets w/3 Caresite Needle-Free Injection Sites recalled	B. Braun Medical	Packaging Defects	Nationwide

More recalls from B. Braun Medical

All 447

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10 Jun 2026Device	CLASS I	Design Options Spinal Tray Spinal Needle Anesthesia recalled	B Braun Medical	Processing Deviation	Nationwide
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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide