What exactly is wrong with the SESK Combined Spinal and Epidural Tray?

The lid of the catheter connector may be in the incorrect position, which could affect the connection and delivery of anesthesia.

Who is affected by this recall?

Healthcare facilities nationwide that received the SESK tray, including units with Product Code SESK and Lot 0062003227.

What should I do if I have this tray?

Stop using the device immediately and follow the manufacturer's recall instructions. Contact your healthcare provider for guidance.

How many units are recalled?

60 units are recalled in this notice. Distribution covers all listed states.

Is there any reported injury related to this recall?

No injuries or incidents are detailed in the recall notice.

What is the recommended remedy?

Patients and healthcare providers should stop using the device and follow recall instructions from B Braun Medical Inc. Notifications are issued by letter.

Where can I find more information?

Visit the FDA enforcement recall page linked in the notice or contact B Braun Medical for guidance.

Will there be a replacement or refund?

Remedies are determined by the manufacturer. Follow recall instructions for next steps.

What is the category and hazard level?

This is a Class II medical device with a high hazard level.

HIGHSeptember 18, 2025

B Braun Medical Recall: 60-Unit Anesthesia Tray Recalled for Catheter Connector Lid Position Issue

Q: How do I identify the affected product?

Check Product Code SESK, UDI-DI 04046955625147, Unit of Use 04046955625130, and Lot Number 0062003227.

B BRAUN MEDICAL INC recalls 60 units of SESK Combined Spinal and Epidural Tray nationwide. The recall targets products distributed to all 50 states. The defective lid on the catheter connector may be in the incorrect position, posing a high-risk device issue. Stop using immediately and follow company instructions for recall remedies.

Quick Facts at a Glance

Recall Date: September 18, 2025
Hazard Level: HIGH
Brand: B BRAUN MEDICAL
Category: Health & Personal Care
Sold At: Unknown
Geographic Scope: 1 states
At-Risk Groups: GENERAL, PREGNANT

Hazard Information

Potential for the lid of the catheter connector to be in the incorrect position.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter

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About This Product

This product is a spinal and epidural anesthesia tray used in surgical settings to administer anesthetic throughout spinal and epidural procedures.

Why This Is Dangerous

An incorrect lid position on the catheter connector can compromise the integrity of the connection and delivery path for anesthetic drugs.

Industry Context

This recall is not identified as part of a broader industry pattern.

Real-World Impact

No injuries reported yet; highest risk is improper administration of anesthesia if used with a mispositioned lid.

Practical Guidance

How to identify if yours is affected

Verify Product Code SESK.
Check UDI-DI 04046955625147 (Primary) and 04046955625130 (Unit of Use).
Inspect Lot Number 0062003227.
Confirm model references REF: 530185.

Where to find product info

UDI labels on the packaging and the product itself; look for Product Code SESK and Lot 0062003227.

What timeline to expect

Remedies and replacement process will be communicated by the manufacturer; typical timelines vary by facility.

If the manufacturer is unresponsive

Document all communications with the manufacturer.
Contact hospital risk management for guidance.
File recall with the appropriate regulatory body if needed.

How to prevent similar issues

Verify tray compatibility before use.
Maintain strict inventory controls to isolate recalled lots.
Stay updated with manufacturer recall notices.

Documentation advice

Keep copies of the recall notice, purchase records, and all correspondence with the manufacturer.

Product Details

Product: SESK Combined Spinal and Epidural Tray 2. Includes PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Code: SESK. UDI-DI 04046955625147. Unit of Use: 04046955625130. Lot Number: 0062003227. Quantity: 60 units. Distribution: Nationwide to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.

Reported Incidents

No specific injuries or adverse events are detailed in the recall notice. The status is active with a high-hazard designation.

Key Facts

60 units recalled nationwide
Product Code SESK with UDI-DI 04046955625147
Lot Number 0062003227
Hazard: Catheter connector lid position may be incorrect
Recall date 2025-09-18, report date 2025-10-15
Active recall status, high hazard level

View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANT

Injury Types

ELECTRICALLACERATIONSUFFOCATIONOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeCombined Spinal and Epidural Anesthesia Tray

Product Details

Sep 18, 2025

B BRAUN MEDICAL

Potential for