B. Braun Recalls FEF 100N Flat Epidural Filters Due to Membrane Damage
B. Braun Medical is recalling 250 units of FEF 100N Flat Epidural Filters because damage to the filter membrane prevents the device from achieving its intended filter capacity.
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 is classified as FDA Class II, and the defect involves a medical device failing to achieve its intended filter capacity, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
B. Braun Medical, Inc. is recalling 250 units of the FEF 100N Flat Epidural Filter NRFIT (Catalog # 339160). The recall is being conducted because the filter capacity is not achieved due to damage of the filter membrane.
The affected units are identified by Lot # 0061526085 and UDI 04046964941054. The products were distributed to facilities in California, Florida, Missouri, Texas, Minnesota, Alabama, Georgia, North Carolina, Illinois, and Pennsylvania.
Healthcare facilities should stop using the affected devices and contact B. Braun Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- FEF 100N FLAT EPIDURAL FILTER NRFIT Catalog # 339160
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Epidural Filter
- Hazard
- Affected units
- 250
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 # 0061526085 UDI: 04046964941054
Distribution
Part of a larger recall action
This product is one of 9 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.
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