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U.S. Department of Health and Human Services

Class 2 Device Recall Design Options

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 Class 2 Device Recall Design Optionssee related information
Date Initiated by FirmDecember 04, 2024
Date PostedJanuary 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1021-2025
Recall Event ID 95874
Product Classification Spinal epidural anesthesia kit - Product Code OFT
ProductDesign Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Code Information UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer Reason
for Recall		Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionB Braun issued Urgent Medical Device Correction Notification letter on 12/04/24 via USPS Certified Mail. Letter states reason for recall, health risk and action to take: 1. Review the Medical Device Correction Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons are informed about this voluntary correction. If you have further distributed the affected product, please forward this notice to your consignees. The correction is to be extended to the hospital/healthcare facility level. 2. Post this notification where the affected products are stored. Additional catheter connectors are being supplied to you and should be stored where the affected inventory is utilized. In the event that an incorrect catheter connector is identified, please utilize these additional devices to facilitate replacement. 3. Returned the completed Urgent Medical Device Correction Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or email to recalls@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). Adverse reactions or quality problems experienced with this product, or questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-844-903-6417.
Quantity in Commerce1090 units
DistributionUS Nationwide distribution in the states of MO, OK.
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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