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.
FDA Recall Z-1703-2016 · Posted 2016-05-20
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Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2016-04-26
Date Terminated2017-03-10
Product Quantity5,980 units [Lot # 0061482060 (3,340 units); Lot # 0061486821 (2,640 units)]
Reason for Recall
Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard.
Firm 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 [email protected] 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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