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U.S. Department of Health and Human Services

Class 2 Device Recall ALLERGAN UNIVERSAL FILL KIT

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  Class 2 Device Recall ALLERGAN UNIVERSAL FILL KIT see related information
Date Initiated by Firm September 26, 2023
Date Posted November 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-0134-2024
Recall Event ID 93074
510(K)Number K853014  
Product Classification Tissue expander and accessories - Product Code LCJ
Product ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Code Information UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact BBMI Postmarket Surveillance Department
888-425-1464
Manufacturer Reason
for Recall		 Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
FDA Determined
Cause 2		 Process control
Action On September 26, 2023, the firm notified customers via Urgent Product Recall Notification letters. Customers were informed of the potential for leakage at the male Luer lock site. Customers were instructed to report total amount of impacted product on hand to the firm, after which B Braun Customer Support will contact the customer with instructions on how to return the product for credit or replacement depending on the customer's need. Questions about this recall may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464.
Quantity in Commerce 27.432 units
Distribution Worldwide distribution - US Nationwide and the countries of Canada and Singapore.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = LCJ and Original Applicant = MCGHAN MEDICAL CORP.
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