| | Class 1 Device Recall B.Braun Spinocan |  |
| Date Initiated by Firm | May 06, 2026 |
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| Date Posted | June 03, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2278-2026 |
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| Recall Event ID |
98838 |
| Product Classification |
Spinal anesthesia kit - Product Code OFU
|
| Product | Design Options Spinal Tray
Material Description (Material Number):
SSK HACKENSACK MEDICAL CTR 20061890 (560074),
SSK SUTTER COMMUNITY HOSPITAL (560214),
SSK BJC HEALTH SYSTEMS (ORIGINAL CUST) (560272),
SSK CA PACIFIC MED. CTR (ORIGINAL CUST) (560327),
SSK TORRANCE MEMORIAL HOSPITAL (560394),
SSK SURGERY ONE 20070208 (560428),
SSK LUTHERN GENERAL HOSP (ORIGINAL CUST) (560462),
SSK HOAG MEMORIAL HOSPITAL (560465),
SSK BUPIVACAINE TRAY 2068824 (560476),
SSK KAISER FOUNDATION HOSPITAL (560497),
SSK THOMAS JEFFERSON UNIV HOSP (560513),
SSK OVERLAKE MEDICAL CENTER (560521),
SSK CUSTOM SPINAL TRAY (560523),
SSK ORLANDO REGIONAL MED CENTER (560533),
SSK BON SECOURS HEALTH SYS 20115122 (560538),
SSK MANATEE MEMORIAL (560572),
SSK MOUNT SINAI 27GA PENCAN SPINAL TRAY (560580),
SSK SHANDS TEACHING HOSP. & CLINICS, INC (560584),
SSK UNIVERSITY OF COLORADO (560587),
SSK P25BKG (560603),
SSK P24BKG (560606),
SSK S25BKG (560607),
SSK MAYO CLINIC - BUPIVACAINE TRAY (560609),
SSK THE MEDICAL CENTER (560613),
SSK PENCIL POINT SPINAL TRAY (560619),
SSK EMORY ORTHO & SPINE HOSPITAL-SPINAL (560621),
SSK BSW SPINAL TRAY (560628),
SSK MAYO CLINIC OB DEPT - SPINAL (560645),
SSK BAPTIST HOSPITAL OF MIAMI (560646),
SSK MERCY GILBERT MEDICAL CENTER (560647),
SSK ST.MARY'S HOSPITAL (560648),
SSK HARRIS HEALTH SYSTEM (560660),
OHIO STATE U MEDICAL CTR SPINAL TRAY SSK (560667),
ALBANY MEDICAL CENTER, SSK (560670),
STONY BROOK HOSPITAL - SPINAL TRAY SSK (560672); |
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| Code Information |
1. Material: 560074; UDI-DI Primary/Individual Unit of Use: 04046964317873/04046964317859; Batch Numbers: 0061960383, 0061972565;
2. Material: 560214; UDI-DI Primary/Individual Unit of Use: 04046964318061/04046964318054; Batch Numbers: 0061971346, 0061977782;
3. Material: 560272; UDI-DI Primary/Individual Unit of Use: 04046964318108/04046964318085; Batch Numbers: 0061960367, 0061971330;
4. Material: 560327; UDI-DI Primary/Individual Unit of Use: 04046964318221/04046964318207; Batch Numbers: 0061960420, 0061977751;
5. Material: 560394; UDI-DI Primary/Individual Unit of Use: 04046964318429/04046964318405; Batch Numbers: 0061964747, 0061976985, 0061983313;
6. Material: 560428; UDI-DI Primary/Individual Unit of Use: 04046964318610/04046964318597; Batch Numbers: 0061976150, 0061979927;
7. Material: 560462; UDI-DI Primary/Individual Unit of Use: 04046964318764/04046964318740; Batch Number: 0061977772;
8. Material: 560465; UDI-DI Primary/Individual Unit of Use: 04046964318801/04046964318788; Batch Numbers: 0061976120, 0061976122, 0062024615;
9. Material: 560476; UDI-DI Primary/Individual Unit of Use: 04046964318948/04046964318931; Batch Numbers: 0061964879, 0061977776, 0061985361;
10. Material: 560497; UDI-DI Primary/Individual Unit of Use: 04046964319136/04046964319112; Batch Numbers: 0061967077, 0061985362;
11. Material: 560513; UDI-DI Primary/Individual Unit of Use: 04046964319273/04046964319259; Batch Numbers: 0061961836, 0061977766;
12. Material: 560521; UDI-DI Primary/Individual Unit of Use: 04046964319440/04046964319426; Batch Numbers: 0061967083, 0061977226;
13. Material: 560523; UDI-DI Primary/Individual Unit of Use: 04046964319471/04046964319457; Batch Numbers: 0061952176, 0061971321;
14. Material: 560533; UDI-DI Primary/Individual Unit of Use: 04046964319518/04046964319495; Batch Numbers: 0061954120, 0061971287, 0061971288;
15. Material: 560538; UDI-DI Primary/Individual Unit of Use: 04046964319587/04046964319563; Batch Numbers: 0061971325, 0061973771;
16. Material: 560572; UDI-DI Primary/Individual Unit of Use: 04046964319990/04046964319976; Batch Number: 0061961001;
17. Material: 560580; UDI-DI Primary/Individual Unit of Use: 04046964320194/04046964320170; Batch Number: 0061967090;
18. Material: 560584; UDI-DI Primary/Individual Unit of Use: 04046964320293/04046964320286; Batch Number: 0061961847;
19. Material: 560587; UDI-DI Primary/Individual Unit of Use: 04046964320408/04046964320378; Batch Number: 0061972579;
20. Material: 560603; UDI-DI Primary/Individual Unit of Use: 04046964320842/04046964320828; Batch Numbers: 0061951279, 0061954147, 0061958274, 0061969404, 0061969405, 0061970744, 0061974805;
21. Material: 560606; UDI-DI Primary/Individual Unit of Use: 04046964320958/04046964320927; Batch Numbers: 0061965746, 0061965762, 0061971283, 0061971284, 0061971285;
22. Material: 560607; UDI-DI Primary/Individual Unit of Use: 04046964320989/04046964320965; Batch Numbers: 0061958137, 0061972577, 0061985364;
23. Material: 560609; UDI-DI Primary/Individual Unit of Use: 04046964321047/04046964321030; Batch Numbers: 0061958142, 0061975207, 0061985374;
24. Material: 560613; UDI-DI Primary/Individual Unit of Use: 04046964321153/04046964321146; Batch Number: 0061972578;
25. Material: 560619; UDI-DI Primary/Individual Unit of Use: 04046964321306/04046964321290; Batch Numbers: 0061954114, 0061971313;
26. Material: 560621; UDI-DI Primary/Individual Unit of Use: 04046964321375/04046964321368; Batch Numbers: 0061961853, 0061976112, 0061977798;
27. Material: 560628; UDI-DI Primary/Individual Unit of Use: 04046964526749/04046964526732; Batch Numbers: 0061954111, 0061959460;
28. Material: 560645; UDI-DI Primary/Individual Unit of Use: 04046964809088/04046964809071; Batch Numbers: 0061967991, 0061977778;
29. Material: 560646; UDI-DI Primary/Individual Unit of Use: 04046964809101/04046964809095; Batch Number: 0061957394;
30. Material: 560647; UDI-DI Primary/Individual Unit of Use: 04046964809125/04046964809118; Batch Numbers: 0061971336, 0061977571, 0061985370;
31. Material: 560648; UDI-DI Primary/Individual Unit of Use: 04046964809149/04046964809132; Batch Numbers: 0061961002, 0061977800, 0061977801;
32. Material: 560660; UDI-DI Primary/Individual Unit of Use: 04046955331864/04046955331857; Batch Number: 0061958133;
33. Material: 560667; UDI-DI Primary/Individual Unit of Use: 04046955595891/04046955595884; Batch Numbers: 0061966001, 0061976124, 0061977803;
34. Material: 560670; UDI-DI Primary/Individual Unit of Use: 04046955595945/04046955595938; Batch Number: 0061972569;
35. Material: 560672; UDI-DI Primary/Individual Unit of Use: 04046955595983/04046955595976; Batch Numbers: 0061967078, 0061977783; |
| FEI Number |
2521402
|
Recalling Firm/
Manufacturer |
B Braun Medical Inc
824 12th Ave
Bethlehem PA 18018-3524
|
| For Additional Information Contact | Allison Longenhagen
001-484-2408373 |
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Manufacturer Reason
for Recall | A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On May 6, 2026, URGENT MEDICAL DEVICE RECALL were sent to customers.
Actions to be taken:
- Check inventory for affected product and return to B Braun. The return process will begin when B Braun received the Acknowledgement Form.)
- If you are a distributor and have further distributed the product, please forward this notice to your consignees. This recall is to be extended to the hospital/healthcare facility level.
Should there be any questions, comments, or concerns, please feel free to contact us via email at recalls@bbraunusa.com or via phone at 844-903-6417 Monday through Friday, 8:00am-5:00pm EST. |
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| Quantity in Commerce | 104,720 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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