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U.S. Department of Health and Human Services

Class 2 Device Recall Introcan Safety

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  Class 2 Device Recall Introcan Safety see related information
Date Initiated by Firm September 01, 2022
Date Posted October 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-0009-2023
Recall Event ID 90830
510(K)Number K020785  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Code Information UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01 Apr 2027 22E30G8241 01 May 2027 22E30G8242 01 May 2027
Recalling Firm/
B Braun Medical Inc
200 Boulder Dr
Breinigsville PA 18031-1532
For Additional Information Contact BBMI Postmarket Surveillance Department
Manufacturer Reason
for Recall
Potential for leakage at the catheter hub.
FDA Determined
Cause 2
Process control
Action On September 1, 2022, the firm notified customers of the recall via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine recalled product. Customers should return completed response forms to B. Braun Medical Inc. Once the form is received, B. Braun Customer Support will contact customers with instructions on returning any impacted product and provide credit and/or replacement of the product based on the individual customer's needs.
Quantity in Commerce 94,000 US
Distribution Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
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 = FOZ and Original Applicant = B. BRAUN MEDICAL, INC.