The Recall Desk
HighFDA (Devices)·Z-2470-2019·Announced 2019-09-11

B. Braun Epidural Tray Recall Due to Filter Membrane Damage

B. Braun Medical is recalling 960 epidural trays because filter membrane damage prevents the filter from achieving its intended 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. The hazard involves a functional defect in a medical device (filter membrane damage) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling 960 units of the CE17TKFCN Epidural Tray with 17GA Tuohy Needle (Catalog # 339186). The recall is being conducted because the filter capacity is not achieved due to damage of the filter membrane.

The affected products are distributed in California, Florida, Missouri, Texas, Minnesota, Alabama, Georgia, North Carolina, Illinois, and Pennsylvania. The recall includes units from Lot # 0061536043 (Expiration: 8/31/2018) and Lot # 0061620273 (Expiration: 11/30/2019). The UDI for the product is 04046964941399.

Healthcare providers and consumers should stop using these specific lots of epidural trays and contact B. Braun Medical for further instructions or replacement.

The recalled product

Product
CE17TKFCN EPID TRAY W/ 17GA TUOHY NRFIT Catalog # 339186
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Epidural Trays
Hazard
Affected units
960

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.

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Same hazard · filter defect

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