Agency classClass IIOur severity:High FDA (Devices)·Z-2559-2021·Announced 2021-10-06

Outlook Pump Primary Administration Set Recalled for Potential Leakage and Medication Underdosing

B. Braun Medical is recalling the Outlook Pump Primary Administration Set due to potential leakage that could delay medication delivery and cause incomplete dosing of critical fluids in epidural administration.

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 risk-of-harm medical device where serious potential complications including bloodstream infections and medication underdosing exist. The FDA Class II classification and the absence of any reported illnesses or injuries in the source documentation place this at the High (3) level rather than Severe (4).

Plain-English summary

B. Braun Medical, Inc. is recalling the Outlook Pump Primary Administration Set with micro tubing for epidural administration (Reference V7453). The recalled pump sets are designed for use with the Outlook Safety Infusion System or Horizon NXT Pump for the infusion of parenteral fluids. The recall is due to potential leakage within the cassette portion of the pump sets, which could result in delays in medication administration, under-delivery or incomplete dosing of medications, and an increased risk of bloodstream infections.

Approximately 1,080 units have been affected and distributed worldwide, including nationwide distribution in the United States and Canada. The affected products can be identified by Lot Code 0061770205 and Device Identifier (DI) 04046964189388.

Facilities and providers using this product should contact B. Braun Medical, Inc. for instructions regarding proper handling and replacement of affected units.

The recalled product

Product: Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7453
Manufacturer: B. Braun Medical, Inc.
Category: Medical Device — Infusion / Epidural Administration
Hazard: leakage
medication-delay
underdosing
bloodstream-infection
Affected units: 1,080

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: 0061770205 DI: 04046964189388

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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