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.
Potential for the lid of the catheter connector to be in the incorrect position.
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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This product is a spinal and epidural anesthesia tray used in surgical settings to administer anesthetic throughout spinal and epidural procedures.
An incorrect lid position on the catheter connector can compromise the integrity of the connection and delivery path for anesthetic drugs.
This recall is not identified as part of a broader industry pattern.
No injuries reported yet; highest risk is improper administration of anesthesia if used with a mispositioned lid.
UDI labels on the packaging and the product itself; look for Product Code SESK and Lot 0062003227.
Remedies and replacement process will be communicated by the manufacturer; typical timelines vary by facility.
Keep copies of the recall notice, purchase records, and all correspondence with the manufacturer.
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.
No specific injuries or adverse events are detailed in the recall notice. The status is active with a high-hazard designation.
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