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.
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. 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
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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