The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2468-2019·Announced 2019-09-11

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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

Distributed in 10 states:

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.

See all 9 products in this recall →

Related recalls

Same manufacturer · B. Braun Medical, Inc.

See all →

Same hazard · filter failure

See all →

Similar recalls