Agency classClass IIOur severity:High FDA (Devices)·Z-2555-2021·Announced 2021-10-06

B. Braun Pump Set Cassette Leakage Risks Medication Delivery

B. Braun Medical recalls 13,320 pump sets due to cassette leakage that may delay medication administration and cause incomplete dosing or bloodstream infections.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall involving leakage that could delay medication administration and cause incomplete dosing, with potential for serious bloodstream infections. No reported illnesses have been documented, making this a risk-of-harm situation without yet-reported injury, which corresponds to Score 3 per the severity rubric.

Plain-English summary

B. Braun Medical, Inc. is recalling 13,320 units of PUMP SET, 15 DR, 3 CARESITE, 127-inch single-use pump sets used with the Outlook Safety Infusion System and Horizon NXT Pump for parenteral fluid infusion.

The pump sets may leak within the cassette portion. This leakage can delay medication administration and result in under-delivery or incomplete dosing of medications. Leaking fluid could also potentially lead to bloodstream infections.

The affected pump sets were distributed nationwide in the United States and to Canada. Lot codes 0061756804, 0061757753, and 0061777804 are included in this recall.

If you have any of these pump sets, discontinue use immediately. Contact B. Braun Medical, Inc. for instructions on return or replacement.

The recalled product

Product: PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Infusion Equipment
Hazard: pump-leakage
medication-delivery-delay
underdosing
bloodstream-infection
Affected units: 13,320

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot Code: 0061756804 0061757753 0061777804 DI: 04046955137015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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