The Recall Desk
HighFDA (Devices)·Z-2166-2013·Announced 2013-09-18

B. Braun Recalls Outlook Safety Infusion System Burette Sets

B. Braun Medical is recalling 900 Outlook Safety Infusion System Burette Sets because one injection site and valve were assembled upside down.

What this means for you

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: The recall involves a medical device with a structural assembly defect (upside-down valve) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

B. Braun Medical, Inc. is recalling 900 units of the Outlook Safety Infusion System Burette Set (Catalog Number 375038, Lot Number 0061317318). The product is used for intravenous fluid administration. The recall was initiated after reports indicated that one of the ULTRASITE injection sites and the corresponding low pressure backcheck valve were assembled upside down.

The affected units were distributed in the states of Florida, New York, New Jersey, and Texas. The expiration date for the recalled lot is 04/30/2016.

Healthcare facilities and consumers should stop using the affected product immediately. B. Braun Medical is the recalling firm responsible for managing the recall.

The recalled product

Product
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Infusion Systems
Hazard
Affected units
900

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 (3)

  • Catelog Number 375038
  • Lot Number 0061317318
  • Expiration Date: 04/30/2016

Distribution

Distributed in 4 states:

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