B. Braun Recalls Infusomat Space Pump IV Sets Due to Missing Filter
B. Braun Medical is recalling 1,872 Infusomat Space Pump IV Sets because some units may lack the required air-eliminating filter.
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 where a missing air-eliminating filter poses a risk of harm (air embolism or particulate exposure) to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,872 units of the Infusomat Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter (Product Code 363420, Lot Number 0061583973). The recall was initiated because there is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
The affected product is a latex-free IV infusion set intended to be used with the Infusomat Space Pump to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While not listed in the labeling, the filter is known to be used for the removal of particulate matter for some medications and at-risk patient populations.
The recalled units were distributed in the United States to California, Illinois, and Texas, and internationally to Canada. Consumers and healthcare facilities should stop using the affected IV sets and contact B. Braun Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — IV Infusion Set
- Affected units
- 1,872
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 Number: 0061583973
Distribution
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