B BRAUN MEDICAL INC recalls Design Options
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, 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.
Lot / code information
- REF
- 530029; Product Code: SESK
- UDI
- (Primary): 04046964305245
- UDI
- (Unit of Use): 04046964305238
- Lot #
- 0062012031. 2
- REF
- 530048; Product Code: SESK
- UDI
- (Primary): 04046964305313
- UDI
- (Unit of Use): 04046964305306
- Lot #
- 0062006298. 3
- REF
- 530155; Product Code: SESK
- UDI
- (Primary): 04046964306211
- UDI
- (Unit of Use): 04046964306204
- Lot #
- 0062012054. 4
- REF
- 530159; Product Code: SESK
- UDI
- (Primary): 04046964669286
- UDI
- (Unit of Use): 04046964669279
- Lot #
- 0062012025. 5
- REF
- 530169; Product Code: SESK
- UDI
- (Primary): 04046964808920
- UDI
- (Unit of Use): 04046964808913
- Lot #
- 0062012035. 6
- REF
- 530171; Product Code: SESK
- UDI
- (Primary): 04046964950391
- UDI
- (Unit of Use): 04046964950384
- Lot #
- 0062006303. 7
- REF
- 530180; Product Code: SESK
- UDI
- (Primary): 04046955156443
- UDI
- (Unit of Use): 04046955156436
- Lot #
- 0062000738. 8
- REF
- 530197; Product Code: SESK
- UDI
- (Primary): 04046955619337
- UDI
- (Unit of Use): 04046955619320
- Lot #
- 0062003710. 9
- REF
- 530194; Product Code: SESK
- UDI
- (Primary): 4046955589388
- UDI
- (Unit of Use): 4046955589371
- Lot #
- 0062014360. 10
- REF
- 530199; Product Code: SESK
- UDI
- (Primary): 04046955619375
- UDI
- (Unit of Use): 04046955619368
- Lot #
- 0062001876. 11
- REF
- 530160; Product Code: SESK
- UDI
- (Primary): 04046964813993
- UDI
- (Unit of Use): 04046964813986
- Lot #
- 0062011011. 12
- REF
- 530184; Product Code: SESK
- UDI
- (Primary): 04046955156528
- UDI
- (Unit of Use): 04046955156511
- Lot #
- 0062003228. Expiration Date: 07/31/2026
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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 detailsHide
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.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0124-2026
- FDA device classification · OGEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5120The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find B BRAUN MEDICAL INCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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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