Class II U.S. Food and Drug Administration

B Braun Medical Inc Design Options, Pain Management Tray. Product Code: Sesk. Product recall: Potential for the lid of the catheter connector to be in the incorrect

Recall published 1+ years ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Potential for the lid of the catheter connector to be in the incorrect position.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0124-2026
Published
October 15, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
B Braun Medical Inc
Product type
Medical devices
Units affected
2,450 units
Distribution
Nationwide
Made in
United States
Lot / code info
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.
UPC codes
04046964305245, 04046964305238, 04046964305313, 04046964305306, 04046964306211, 04046964306204, 04046964669286, 04046964669279, 04046964808920, 04046964808913, 04046964950391, 04046964950384, 04046955156443, 04046955156436, 04046955619337, 04046955619320, 4046955589388, 4046955589371, 04046955619375, 04046955619368

Products covered by this recall

Design 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.

Check your product

The notice names 48 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04046964305245
  • 04046964305238
  • 04046964305313
  • 04046964305306
  • 04046964306211
  • 04046964306204
  • 04046964669286
  • 04046964669279
  • 04046964808920
  • 04046964808913
  • 04046964950391
  • 04046964950384
  • 04046955156443
  • 04046955156436
  • 04046955619337
  • 04046955619320
  • 4046955589388
  • 4046955589371
  • 04046955619375
  • 04046955619368

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0062012031. 2. REF
  • 0062006298. 3. REF
  • 0062012054. 4. REF
  • 0062012025. 5. REF
  • 0062012035. 6. REF
  • 0062006303. 7. REF
  • 0062000738. 8. REF
  • 0062003710. 9. REF
  • 0062014360. 10. REF
  • 0062001876. 11. REF
  • 0062011011. 12. REF

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 07
  • 31
  • 2026. — 2
  • 450 units

Model or item number

On the rating label, the box or the instruction sheet.

  • 530029
  • SESK
  • 530048
  • 530155
  • 530159
  • 530169
  • 530171
  • 530180
  • 530197
  • 530194
  • 530199
  • 530160
  • 530184

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

B Braun Medical Inc — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: B BRAUN MEDICAL INC — 861 Marcon Blvd, Allentown, PA, 18109-9577

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was B Braun Medical Inc medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04046964305245, 04046964305238, 04046964305313; lot code 0062012031. 2. REF, 0062006298. 3. REF, 0062012054. 4. REF; best-by date 07 or 31; model number 530029, SESK, 530048. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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