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U.S. Department of Health and Human Services

Class 2 Device Recall WHIN Infusion Set

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  Class 2 Device Recall WHIN Infusion Set see related information
Date Initiated by Firm April 26, 2016
Date Posted May 20, 2016
Recall Status1 Terminated 3 on March 10, 2017
Recall Number Z-1703-2016
Recall Event ID 74171
510(K)Number K760388  
Product Classification Catheter, intravascular, diagnostic - Product Code DQO
Product WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734.

Usage: Infusion of solution/medication into implanted intravascular ports.
Code Information Catalog Number 471734, Lot Numbers: 0061482060 and 0061486821, expiration dates :1/31/2021 and 02/28/2021, respectively.
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Robert P. Hubert
610-596-2203
Manufacturer Reason
for Recall		 Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
FDA Determined
Cause 2		 Component design/selection
Action The firm, B. Braun Medical Inc., sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 4/26/2016 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to evaluate their current inventory for the affected lots; fill out the Product Removal Acknowledgement form and record the total number of units found, and return the form to B. Braun Medical Inc. Quality Assurance department by faxing the form to 610-849-1197 or email to PA_Quality Assurance.BBMUS_Service@bbraun.com within two weeks of receipt. A BBMI Customer Support Representative will contact the customer to provide instructions for handling the affected product and arrange for return to BBMI. Should you have any questions or concerns regarding the attached information, please contact our Customer Support Department at (800) 227-2862.
Quantity in Commerce 5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]
Distribution Worldwide distribution: US Distribution to states of: IN, NV, MA, IL, AR, TX, OH, CA, GA, FL, MS, NJ, AL, PA, TN, KY, VA, SC, and country of: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQO and Original Applicant = B. BRAUN INSTRUMENTS
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