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U.S. Department of Health and Human Services

Class 2 Device Recall Perifix

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 Class 2 Device Recall Perifixsee related information
Date Initiated by FirmJuly 31, 2023
Date PostedSeptember 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2627-2023
Recall Event ID 92913
Product Classification Epidural anesthesia kit - Product Code OGE
ProductPerifix / Epidural anesthesia set, medicated
Code Information UDI-DI: 04046964178726 Product Code: 332250; Lot Number 0061863524, expiration date 30.APR.2025
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact
610-596-0500
Manufacturer Reason
for Recall		Product may be mislabeled with an incorrect lid stock label.
FDA Determined
Cause 2		Process control
ActionAn "URGENT MEDICAL DEVICE RECALL" letter dated 8/14/23 was issued to affected customers on 08/14/2023. The letter described the product, problem and actions to be taken. The Customers are instructed to review inventory, cease use and quarantine impacted product and complete and return the Product Recall Acknowledgement Form back to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610)849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraunusa.com. B. Braun Medical will facilitate return of impacted product. If you have any questions, contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.
Quantity in Commerce3440 units
DistributionUS Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, 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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