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Design Options recallZ-0126-2026 · B Braun Medical Inc · initiated Sep 18, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0126-2026
Status
Open, Classified
Initiated by the company
Sep 18, 2025
Posted by the FDA
Oct 9, 2025
Recalling firm
B Braun Medical Inc
Quantity
5,770 units
Product code
OGE
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.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

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.

Devices named in this recall

30 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 97550).

Sources and updates

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