B. Braun Medical Recalls Cont. Epidural Needles Due to Filter Damage
B. Braun Medical is recalling 1,230 units of CE18TKSTN Cont. Epidural Needles 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 (filter membrane damage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,230 units of CE18TKSTN CONT EPID W/SOFT TIP NRFIT (Catalog # 339191). The recall is due to damage of the filter membrane, which results in the filter capacity not being achieved.
The affected lots are # 0061536641 (Expiration: 10/31/2018) and # 0061643652 (Expiration: 11/30/2019). The UDI for the product is 04046964941474. The 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 devices and contact B. Braun Medical, Inc. for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- CE18TKSTN CONT EPID W/SOFT TIP NRFIT Catalog # 339191
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 1,230
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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