Recall Z-1703-2016 ยท DQO Catheter, Intravascular, Diagnostic
B. Braun Medical, Inc.
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.
| Date | May 20, 2016 (initiated Apr 26, 2016) |
| Status | Terminated |
| Reason | Potential for the tip of the Huber needle on the WHIN Infusion Set to protrude from the needle guard. |
| Root cause | 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 Represe |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K760388 | CATHETER, VEIN (VENOFIX) B. Braun Instruments, Nov 2, 1976 |