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U.S. Department of Health and Human Services

Class 2 Device Recall B. BRAUN MEDICAL INC.

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 Class 2 Device Recall B. BRAUN MEDICAL INC.see related information
Date Initiated by FirmJanuary 29, 2026
Date PostedMay 29, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2265-2026
Recall Event ID 98862
Product Classification Spinal epidural anesthesia kit - Product Code OFT
ProductBrand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No
Code Information Lot Code: Model No 530201, UDI-DI (Primary Device) 04046955672196, UDI-DI (Unit Device ID) 04046955672189, Lot Number 0062010965
FEI Number 2521402
Recalling Firm/
Manufacturer		 B Braun Medical Inc
824 12th Ave
Bethlehem PA 18018-3524
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer Reason
for Recall		B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
FDA Determined
Cause 2		Process control
ActionOn January 29, 2026 and May 6, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers to notify them of a recall of a kit component. Actions to be taken include to review inventory to identify affected product, discontinue use and segregate. Using the acknowledgement form, respond to B Braun who will send further instructions to return the product. Should there be any questions, comments, or concerns regarding the product you have received, please feel free to contact (844-903-6417) or recalls@bbraunusa.com;
Quantity in Commerce1730
DistributionUS Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
Total Product Life CycleTPLC Device Report
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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