B. Braun Medical Recalls Espocan Spinal/Epidural Trial Needles
B. Braun Medical is recalling 100 units of Espocan Spinal/Epidural Trial Needles because damage to the filter membrane 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, and the source text does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 100 units of the ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT (Catalog # 339114). The recall was initiated because the filter capacity is not achieved due to damage of the filter membrane.
The affected product is identified by Lot # 0061537250 and UDI 04046964940613. The 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 product and contact B. Braun Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- ES1725KFXN ESPOCAN SPINAL/EPID TRY NRFIT Catalog # 339114
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Needles
- Hazard
- Affected units
- 100
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 # 0061537250 UDI: 04046964940613
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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