Infusomat Administration Sets recalled for tubing dimension defects
B. Braun Infusomat Administration Sets may have incorrect tubing dimensions that cause false air-in-line alarms, interrupting medication delivery. The defects may prevent critical medications from reaching patients.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This FDA Class I recall describes potential for serious patient harm including life-threatening therapy interruptions, particularly in patients dependent on continuous critical medications. No reported deaths or injuries are documented in the source text, placing this at Severe rather than Critical per the rubric.
Plain-English summary
B. Braun Medical, Inc. is recalling certain Infusomat Administration Sets across multiple product codes due to manufacturing defects. The tubing in these sets may have an outer diameter that varies from specifications or may be shorter than intended.
These tubing dimension defects can trigger false air-in-line alarms that stop the infusion pump and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients, particularly those receiving critical medications such as vasopressors or other life-sustaining therapies. Such interruptions may be life-threatening or may lead to death.
The affected products have been distributed across the United States, Canada, and Germany. Patients receiving infusions through these administration sets may be at risk.
Patients and healthcare providers should inspect administration sets for tubing defects and discontinue use of affected units. Healthcare facilities should review their inventory using the affected product codes and lot numbers. Contact B. Braun Medical, Inc. for information on replacements or to report any adverse events.
The recalled product
- Product
- Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL…
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 33,820,976
Distribution
Distributed nationwide across the United States.
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