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U.S. Department of Health and Human Services

Class 2 Device Recall SESK PARKLAND MEMORIAL FX CSE TRAY.

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 Class 2 Device Recall SESK PARKLAND MEMORIAL FX CSE TRAY.see related information
Date Initiated by FirmSeptember 18, 2025
Date PostedOctober 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0124-2026
Recall Event ID 97550
Product Classification Epidural anesthesia kit - Product Code OGE
ProductDesign Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL. 11. SESK, BSW SPINAL EPIDURAL TRAY. 12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.
Code Information 1. REF: 530029; Product Code: SESK; UDI-DI (Primary): 04046964305245; UDI-DI (Unit of Use): 04046964305238; Lot Number: 0062012031. 2. REF: 530048; Product Code: SESK; UDI-DI (Primary): 04046964305313; UDI-DI (Unit of Use): 04046964305306; Lot Number: 0062006298. 3. REF: 530155; Product Code: SESK; UDI-DI (Primary): 04046964306211; UDI-DI (Unit of Use): 04046964306204; Lot Number: 0062012054. 4. REF: 530159; Product Code: SESK; UDI-DI (Primary): 04046964669286; UDI-DI (Unit of Use): 04046964669279; Lot Number: 0062012025. 5. REF: 530169; Product Code: SESK; UDI-DI (Primary): 04046964808920; UDI-DI (Unit of Use): 04046964808913; Lot Number: 0062012035. 6. REF: 530171; Product Code: SESK; UDI-DI (Primary): 04046964950391; UDI-DI (Unit of Use): 04046964950384; Lot Number: 0062006303. 7. REF: 530180; Product Code: SESK; UDI-DI (Primary): 04046955156443; UDI-DI (Unit of Use): 04046955156436; Lot Number: 0062000738. 8. REF: 530197; Product Code: SESK; UDI-DI (Primary): 04046955619337; UDI-DI (Unit of Use): 04046955619320; Lot Number: 0062003710. 9. REF: 530194; Product Code: SESK; UDI-DI (Primary): 4046955589388; UDI-DI (Unit of Use): 4046955589371; Lot Number: 0062014360. 10. REF: 530199; Product Code: SESK; UDI-DI (Primary): 04046955619375; UDI-DI (Unit of Use): 04046955619368; Lot Number: 0062001876. 11. REF: 530160; Product Code: SESK; UDI-DI (Primary): 04046964813993; UDI-DI (Unit of Use): 04046964813986; Lot Number: 0062011011. 12. REF: 530184; Product Code: SESK; UDI-DI (Primary): 04046955156528; UDI-DI (Unit of Use): 04046955156511; Lot Number: 0062003228. Expiration Date: 07/31/2026.
Recalling Firm/
Manufacturer		 B BRAUN MEDICAL INC
861 Marcon Blvd
Allentown PA 18109-9577
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer Reason
for Recall		Potential for the lid of the catheter connector to be in the incorrect position.
FDA Determined
Cause 2		Process control
ActionB Braun notified consignees on about 09/18/2025 via USPS certified mailed URGENT MEDICAL DEVICE CORRECTION NOTIFICATION. Consignees were instructed to, where possible, have a second kit or additional catheter connector available at the point of use and upon opening the kit, verify the correct catheter connector is present. If the affected component is detected, discard and do not use. Consignees were also instructed to review the Medical Device Correction Notification and ensure all users in your organization and other concerned persons are informed, if affected units have been further distributed, notify customers, post the notification where affected units are stored, and complete and return the "Urgent Medical Device Correction Acknowledgement Form." Additionally, if consignees have identified affected units in inventory, they may order one case (50 pieces) of affected sterilized single use catheter connectors to have on hand.
Quantity in Commerce2,450 units
DistributionNationwide distribution 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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