Combined spinal epidural trays recalled over catheter connector lid position issue
B. Braun is recalling 60 Combined Spinal and Epidural Anesthesia Tray 2 units because the lid of the catheter connector may be in the incorrect position.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record describes a component position defect without stating a hazard, clinical consequence or reported harm.
Plain-English summary
Combined Spinal and Epidural Anesthesia Tray 2, containing a PERIFIX 17 Ga. x 3-1/2 in. Tuohy epidural needle, a PENCAN 27 Ga. x 5 in. spinal needle and a 19 Ga. closed tip PERIFIX FX springwound epidural catheter, product code SESK, is being recalled because of the potential for the lid of the catheter connector to be in the incorrect position.
The recall covers 60 units, REF 530185, carrying primary UDI-DI 04046955625147 and unit-of-use UDI-DI 04046955625130. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the connector lid position and does not state any injury or clinical consequence. Facilities should check affected lots and follow B. Braun's instructions.
The recalled product
- Product
- Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Medical Device — Anesthesia tray
- Affected units
- 60
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 (5)
- REF: 530185
- Product Code: SESK
- UDI-DI (Primary): 04046955625147
- UDI-DI (Unit of Use): 04046955625130
- Lot Number: 0062003227. Expiration Date: 07/31/2026.
Distribution
Part of a larger recall action
This product is one of 13 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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