B. Braun Medical Recalls Epidural Tuohy Needle Filters Due to Membrane Damage
B. Braun Medical is recalling 540 units of CE17TKN epidural Tuohy needle filters because the filter membrane is damaged, preventing 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. 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.
Plain-English summary
B. Braun Medical, Inc. is recalling 540 units of CE17TKN CONT EPIDURALTUOHY NRFIT (Catalog # 339183) medical devices. The recall is being conducted because the filter capacity is not achieved due to damage of the filter membrane.
The affected products are identified by Lot # 0061536635 (Expiration: 10/31/2018) and Lot # 0061620271 (Expiration: 11/30/2019). The Universal Device Identifier (UDI) for the product is 04046964941337. These units were distributed to facilities in California, Florida, Missouri, Texas, Minnesota, Alabama, Georgia, North Carolina, Illinois, and Pennsylvania.
Healthcare providers and consumers should stop using the affected devices and contact B. Braun Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 540
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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