B BRAUN MEDICAL INC: Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDICAL CTR 20064586. 6. CESK ALBANY MEDICAL CENTER. 7. CESK EPIDURAL BLOCK TRAY. 8. CESK, BSW EPIDURAL TRAY. 9. CESK HOWARD COUNTY GENERAL. 10. CESK CE17TKFC10L. 11. CESK WILLIAMSON MEDICAL CENTER. 12. CESK FLORIDA HOSPITAL. 13. CESK RIVERSIDE HEALTH SYSTEM. 14. CESK MAYO CLINIC OB. 15. CESK PRESBYTERIAN HOSPITAL DALLAS. 16. CESK HOUSTON METHODIST HOSPITAL. 17. CESK OHIO STATE UNIV MEDICAL CENTER. 18. CESK NORTONS WOMEN'S AND CHILDREN'S. 19. CESK BEN TAUB. 20. CESK PENN MEDICINE CONTINUOUS-ORIG CUST. 21. CESK ALLEGHENY GENERAL HOSPITAL. 22. CESK UNIVERSITY OF ILLINOIS MED CTR. 23. CESK RUSH UNIVERSITY MEDICAL CENTER. 24. CESK ST. JOSEPH MEDICAL CENTER. 25. CESK INTEGRIS HEALTH. 26. CESK UMASS MEMORIAL. 27. CESK STANFORD UNIV HOSP 20054718. 28. CESK OVERLAKE HOSPITAL. 29. CESK CHRIST HOSPITAL 20057985. 30. CESK NEWTON-WELLESLEY HOSPITAL.

Recall number

Z-0126-2026

Recalling firm

B BRAUN MEDICAL INC

Product

Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDICAL CTR 20064586. 6. CESK ALBANY MEDICAL CENTER. 7. CESK EPIDURAL BLOCK TRAY. 8. CESK, BSW EPIDURAL TRAY. 9. CESK HOWARD COUNTY GENERAL. 10. CESK CE17TKFC10L. 11. CESK WILLIAMSON MEDICAL CENTER. 12. CESK FLORIDA HOSPITAL. 13. CESK RIVERSIDE HEALTH SYSTEM. 14. CESK MAYO CLINIC OB. 15. CESK PRESBYTERIAN HOSPITAL DALLAS. 16. CESK HOUSTON METHODIST HOSPITAL. 17. CESK OHIO STATE UNIV MEDICAL CENTER. 18. CESK NORTONS WOMEN'S AND CHILDREN'S. 19. CESK BEN TAUB. 20. CESK PENN MEDICINE CONTINUOUS-ORIG CUST. 21. CESK ALLEGHENY GENERAL HOSPITAL. 22. CESK UNIVERSITY OF ILLINOIS MED CTR. 23. CESK RUSH UNIVERSITY MEDICAL CENTER. 24. CESK ST. JOSEPH MEDICAL CENTER. 25. CESK INTEGRIS HEALTH. 26. CESK UMASS MEMORIAL. 27. CESK STANFORD UNIV HOSP 20054718. 28. CESK OVERLAKE HOSPITAL. 29. CESK CHRIST HOSPITAL 20057985. 30. CESK NEWTON-WELLESLEY HOSPITAL.

Status

Open, Classified

Initiated

2025-09-18

Posted

2025-10-09

Terminated

not on file

Reason

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

Root cause

Process control

Action

B 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

5,770 units

Distribution

Nationwide 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.

Lot, serial or model codes

1. REF: 551028; Product Code: CESK; UDI-DI (Primary): 04046964306334; UDI-DI (Unit of Use): 04046964306327; Lot Number: 0062017630. 2. REF: 551474; Product Code: CESK; UDI-DI (Primary): 04046964306938; UDI-DI (Unit of Use): 04046964306921; Lot Number: 0062006292. 3. REF: 551630; Product Code: CESK; UDI-DI (Primary): 04046964307560; UDI-DI (Unit of Use): 04046964307546; Lot Number: 0062017605. 4. REF: 551749: Product Code: CESK; UDI-DI (Primary): 04046964307942; UDI-DI (Unit of Use): 04046964307935; Lot Number: 0062017615. 5. REF: 551769: Product Code: CESK; UDI-DI (Primary): 04046964308024; UDI-DI (Unit of Use): 04046964308017; Lot Number: 0062006304. 6. REF: 551998: Product Code: CESK; UDI-DI (Primary): 04046964310942; UDI-DI (Unit of Use): 04046964310928; Lot Number: 0062014368. 7. REF: 552006: Product Code: CESK; UDI-DI (Primary): 04046964311215; UDI-DI (Unit of Use): 04046964311192; Lot Number: 0062013265. 8. REF: 552076: Product Code: CESK; UDI-DI (Primary): 04046964814013; UDI-DI (Unit of Use): 04046964814006; Lot Number: 0062003111. 9. REF: 552113: Product Code: CESK; UDI-DI (Primary): 04046964950193; UDI-DI (Unit of Use): 04046964950186; Lot Number: 0062006384. 10. REF: 552116: Product Code: CESK; UDI-DI (Primary): 04046964950254; UDI-DI (Unit of Use): 04046964950247; Lot Number: 0061994277. 11. REF: 552119: Product Code: CESK; UDI-DI (Primary): 04046964989780; UDI-DI (Unit of Use): 04046964989773; Lot Number: 0062017951. 12. REF: 552123: Product Code: CESK; UDI-DI (Primary): 04046955057788; UDI-DI (Unit of Use): 04046955057771; Lot Number: 0062003214. 13. REF: 552126: Product Code: CESK; UDI-DI (Primary): 04046955056903; UDI-DI (Unit of Use): 04046955056897; Lot Number: 0061999998. 14. REF: 552133: Product Code: CESK; UDI-DI (Primary): 04046955127801; UDI-DI (Unit of Use): 04046955127795; Lot Number: 0062012017. 15. REF: 552135: Product Code: CESK; UDI-DI (Primary): 04046955127849; UDI-DI (Unit of Use): 04046955127832; Lot Number: 0062013246. 16. REF: 552136: Product Code: CESK; UDI-DI (Primary): 04046955127863; UDI-DI (Unit of Use): 04046955127856; Lot Number: 0062003706. 17. REF: 552147: Product Code: CESK; UDI-DI (Primary): 04046955184071; UDI-DI (Unit of Use): 04046955186402; Lot Number: 0062017607. 18. REF: 552152: Product Code: CESK; UDI-DI (Primary): 04046955214419; UDI-DI (Unit of Use): 04046955264407; Lot Number: 0062006313. 19. REF: 552153: Product Code: CESK; UDI-DI (Primary): 04046955214426; UDI-DI (Unit of Use): 04046955243037; Lot Number: 0062017625. 20. REF: 552174: Product Code: CESK; UDI-DI (Primary): 04046955589449; UDI-DI (Unit of Use): 04046955589432; Lot Number: 0062006317. 21. REF: 552176: Product Code: CESK; UDI-DI (Primary): 04046955589487; UDI-DI (Unit of Use): 04046955589470; Lot Number: 0061983245. 22. REF: 552177: Product Code: CESK; UDI-DI (Primary): 04046955596102; UDI-DI (Unit of Use): 04046955596096; Lot Number: 0062014364. 23. REF: 552179: Product Code: CESK; UDI-DI (Primary): 04046955596140; UDI-DI (Unit of Use): 04046955596133; Lot Number: 0062013260. 24. REF: 552180: Product Code: CESK; UDI-DI (Primary): 04046955596164; UDI-DI (Unit of Use): 04046955596157; Lot Number: 0062000125. 25. REF: 552192: Product Code: CESK; UDI-DI (Primary): 04046955701063; UDI-DI (Unit of Use): 04046955701056; Lot Number: 0062005198. 26. REF: 552197: Product Code: CESK; UDI-DI (Primary): 04046955862498; UDI-DI (Unit of Use): 04046955862481; Lot Number: 0062017634. 27. REF: 555098: Product Code: CESK; UDI-DI (Primary): 04046964313578; UDI-DI (Unit of Use): 04046964313554; Lot Number: 0062006293. 28. REF: 555422: Product Code: CESK; UDI-DI (Primary): 04046964315534; UDI-DI (Unit of Use): 04046964315503; Lot Number: 0062019003. 29. REF: 555450: Product Code: CESK; UDI-DI (Primary): 04046964315831; UDI-DI (Unit of Use): 04046964315817; Lot Number: 0062016181. 30. REF: 555484: Product Code: CESK; UDI-DI (Primary): 04046964315954; UDI-DI (Unit of Use): 04046964315930; Lot Number: 0062012043. Expiration Date: 07/31/2026.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OGE

Firm FEI

3013764800

Firm city

Allentown

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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