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U.S. Department of Health and Human Services

Class 2 Device Recall INTROCAN SAFETY 3

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 Class 2 Device Recall INTROCAN SAFETY 3see related information
Date Initiated by FirmFebruary 17, 2025
Date PostedMarch 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1397-2025
Recall Event ID 96293
510(K)NumberK111236 K182870 K213085 
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
ProductIntrocan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Code Information Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.
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		Increased risk for valve housing detachment causing leakage.
FDA Determined
Cause 2		Process control
ActionAn URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 2/13/25 was mailed to consignees notifying them of this product removal. Consignees are instructed to review the recall notification and to forward the notice along to those in their organization and to those to which product was further distributed. Consignees are to quarantine any affected devices in their inventory and coordinate product return by completion and return of the provided Product Recall Acknowledgement Form. Consignees with any questions are to contact B Braun at 844-903-6417.
Quantity in Commerce28,200 units
DistributionDomestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.
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.
510(K) Database510(K)s with Product Code = FOZ
510(K)s with Product Code = FOZ
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