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RecallWatchMedical Device Safety
Class IIOngoingZ-0126-2026

B BRAUN MEDICAL INC recalls Design Options

B BRAUN MEDICAL INCAllentown, PA, United StatesReported Oct 15, 2025 · 9 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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.

Lot / code information

REF
551028; Product Code: CESK
UDI
(Primary): 04046964306334
UDI
(Unit of Use): 04046964306327
Lot #
0062017630. 2
REF
551474; Product Code: CESK
UDI
(Primary): 04046964306938
UDI
(Unit of Use): 04046964306921
Lot #
0062006292. 3
REF
551630; Product Code: CESK
UDI
(Primary): 04046964307560
Show 110 more code fields
UDI
(Unit of Use): 04046964307546
Lot #
0062017605. 4
REF
551749: Product Code: CESK
UDI
(Primary): 04046964307942
UDI
(Unit of Use): 04046964307935
Lot #
0062017615. 5
REF
551769: Product Code: CESK
UDI
(Primary): 04046964308024
UDI
(Unit of Use): 04046964308017
Lot #
0062006304. 6
REF
551998: Product Code: CESK
UDI
(Primary): 04046964310942
UDI
(Unit of Use): 04046964310928
Lot #
0062014368. 7
REF
552006: Product Code: CESK
UDI
(Primary): 04046964311215
UDI
(Unit of Use): 04046964311192
Lot #
0062013265. 8
REF
552076: Product Code: CESK
UDI
(Primary): 04046964814013
UDI
(Unit of Use): 04046964814006
Lot #
0062003111. 9
REF
552113: Product Code: CESK
UDI
(Primary): 04046964950193
UDI
(Unit of Use): 04046964950186
Lot #
0062006384. 10
REF
552116: Product Code: CESK
UDI
(Primary): 04046964950254
UDI
(Unit of Use): 04046964950247
Lot #
0061994277. 11
REF
552119: Product Code: CESK
UDI
(Primary): 04046964989780
UDI
(Unit of Use): 04046964989773
Lot #
0062017951. 12
REF
552123: Product Code: CESK
UDI
(Primary): 04046955057788
UDI
(Unit of Use): 04046955057771
Lot #
0062003214. 13
REF
552126: Product Code: CESK
UDI
(Primary): 04046955056903
UDI
(Unit of Use): 04046955056897
Lot #
0061999998. 14
REF
552133: Product Code: CESK
UDI
(Primary): 04046955127801
UDI
(Unit of Use): 04046955127795
Lot #
0062012017. 15
REF
552135: Product Code: CESK
UDI
(Primary): 04046955127849
UDI
(Unit of Use): 04046955127832
Lot #
0062013246. 16
REF
552136: Product Code: CESK
UDI
(Primary): 04046955127863
UDI
(Unit of Use): 04046955127856
Lot #
0062003706. 17
REF
552147: Product Code: CESK
UDI
(Primary): 04046955184071
UDI
(Unit of Use): 04046955186402
Lot #
0062017607. 18
REF
552152: Product Code: CESK
UDI
(Primary): 04046955214419
UDI
(Unit of Use): 04046955264407
Lot #
0062006313. 19
REF
552153: Product Code: CESK
UDI
(Primary): 04046955214426
UDI
(Unit of Use): 04046955243037
Lot #
0062017625. 20
REF
552174: Product Code: CESK
UDI
(Primary): 04046955589449
UDI
(Unit of Use): 04046955589432
Lot #
0062006317. 21
REF
552176: Product Code: CESK
UDI
(Primary): 04046955589487
UDI
(Unit of Use): 04046955589470
Lot #
0061983245. 22
REF
552177: Product Code: CESK
UDI
(Primary): 04046955596102
UDI
(Unit of Use): 04046955596096
Lot #
0062014364. 23
REF
552179: Product Code: CESK
UDI
(Primary): 04046955596140
UDI
(Unit of Use): 04046955596133
Lot #
0062013260. 24
REF
552180: Product Code: CESK
UDI
(Primary): 04046955596164
UDI
(Unit of Use): 04046955596157
Lot #
0062000125. 25
REF
552192: Product Code: CESK
UDI
(Primary): 04046955701063
UDI
(Unit of Use): 04046955701056
Lot #
0062005198. 26
REF
552197: Product Code: CESK
UDI
(Primary): 04046955862498
UDI
(Unit of Use): 04046955862481
Lot #
0062017634. 27
REF
555098: Product Code: CESK
UDI
(Primary): 04046964313578
UDI
(Unit of Use): 04046964313554
Lot #
0062006293. 28
REF
555422: Product Code: CESK
UDI
(Primary): 04046964315534
UDI
(Unit of Use): 04046964315503
Lot #
0062019003. 29
REF
555450: Product Code: CESK
UDI
(Primary): 04046964315831
UDI
(Unit of Use): 04046964315817
Lot #
0062016181. 30
REF
555484: Product Code: CESK
UDI
(Primary): 04046964315954
UDI
(Unit of Use): 04046964315930
Lot #
0062012043. Expiration Date: 07/31/2026

What the firm 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.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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