B. Braun Medical Recalls Con Epi Tray Due to Filter Membrane Damage
B. Braun Medical is recalling 200 units of Con Epi Trays because damage to the filter membrane prevents the device from achieving its required filter 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, and the hazard involves a functional defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
B. Braun Medical, Inc. is recalling 200 units of the CE17TKFCSN Con Epi Tray with 17G Tuohy Needle (Catalog # 339187). The recall is being conducted because the filter capacity is not achieved due to damage of the filter membrane.
The affected units are identified by Lot # 0061620275 and UDI 04046964941412. The products were distributed to California, Florida, Missouri, Texas, Minnesota, Alabama, Georgia, North Carolina, Illinois, and Pennsylvania.
Consumers and healthcare facilities should stop using the affected products and contact B. Braun Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- CE17TKFCSN CON EPI TRAY W/17G TUHY NRFIT Catalog # 339187
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 200
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 # 0061620275 UDI: 04046964941412
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.
See all 9 products in this recall →Related recalls
Same manufacturer · B. Braun Medical, Inc.
See all →- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun Shands kits contain Mastisol adhesive with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun kits contain Mastisol adhesive with potentially cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · filter defect
See all →- HighMorphine Sulfate Ampuls Recalled for Expired Filters in Cartons
FDA (Drugs) · 2024-03-27
- HighCME America Recalls BodyGuard Microset Infusion Sets Due to Filter Defect
FDA (Devices) · 2020-05-13
- HighB. Braun Epidural Tray Recall Due to Filter Membrane Damage
FDA (Devices) · 2019-09-11