The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2467-2019·Announced 2019-09-11

B. Braun Recalls Spinal and Epidural Trays Due to Filter Damage

B. Braun Medical is recalling 200 units of spinal and epidural trays because the filter membrane is damaged, preventing the device from achieving required 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 involves a medical device with a functional defect (damaged filter membrane) that compromises its intended safety function, representing a risk of harm where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling 200 units of the ES1827KN SPINAL/EPIDURAL TRAY NRFIT (Catalog # 339115). 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 # 0061620288 and UDI 04046964940637. These products were distributed to facilities in California, Florida, Missouri, Texas, Minnesota, Alabama, Georgia, North Carolina, Illinois, and Pennsylvania.

Healthcare providers should stop using the affected trays and contact B. Braun Medical for further instructions or replacement.

The recalled product

Product
ES1827KN SPINAL/EPIDURAL TRAY NRFIT Catalog # 339115
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Surgical Trays
Hazard
Affected units
200

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 # 0061620288 UDI: 04046964940637

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 →

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