Infusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk
B. Braun Medical is recalling infusion pump sets that may leak, potentially causing delayed medication delivery, incomplete dosing, and bloodstream infections.
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: This is an FDA Class II recall of a medical device that presents potential for serious harm, including bloodstream infections and medication under-delivery, without reported illnesses or injuries to date. The risk-of-harm criteria applies, warranting a High severity classification.
Plain-English summary
B. Braun Medical, Inc. is recalling specific infusion pump sets (Ref. 354216, 10 drops/ml) that are designed for use with the Outlook Safety Infusion System and Horizon NXT Pump. The recall affects 55,584 units with worldwide distribution, including the US and Canada.
The pump sets are being recalled due to potential leakage within the cassette portion. This leakage could result in delays in medication administration, under-delivery or incomplete dosing of parenteral fluids, and an increased risk of bloodstream infections.
If you have received or are using one of the affected pump sets (Lot Codes: 0061760493, 0061763906, 0061764288, 0061765128, 0061771281, or Device ID 04046964182273), discontinue use and contact B. Braun Medical, Inc. for instructions on replacement or appropriate handling.
The recalled product
- Product
- 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- leakage
- bloodstream-infection
- medication-under-delivery
Distribution
Distributed nationwide across the United States.
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