Combined Spinal and Epidural Anesthesia Tray Recalled for Connector Lid Defect
B. Braun Medical is recalling 60 units of a Combined Spinal and Epidural Anesthesia Tray because the catheter connector lid may be positioned incorrectly. Affected units were distributed nationwide.
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: This is an FDA Class II medical device used in critical spinal anesthesia procedures. The connector lid positioning defect could prevent proper device assembly or use, qualifying as a risk-of-harm product. No injuries have been reported, consistent with the rubric criterion for Score 3.
Plain-English summary
B. Braun Medical Inc. is recalling 60 units of the Combined Spinal and Epidural Anesthesia Tray 2 (Product Code: SESK). The tray contains a PERIFIX 17 gauge x 3-1/2 inch Tuohy Epidural Needle, a PENCAN 27 gauge x 5 inch Spinal Needle, and a 19 gauge Closed Tip PERIFIX FX Springwound Epidural Catheter. The affected lot number is 0062003227, which expires on July 31, 2026.
The recall is due to a defect where the lid of the catheter connector has the potential to be in an incorrect position. This defect could affect the proper assembly and function of the anesthesia delivery system.
The affected products were distributed nationwide to healthcare facilities across all 50 states.
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
- Hazard
- connector-defect
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
Distributed nationwide across the United States.
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