| Class 2 Device Recall WHIN Infusion Set |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = DQO
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