Recall Z-0193-2020 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer Push Button Blood Collection Set with the needle protector removed prior to needle retractio
| Date | Jul 31, 2019 |
| Status | Terminated |
| Reason | Separation of front and rear barrels upon activation of the safety feature that retracts the needle |
| Root cause | Under Investigation by firm |
| Action | 1. Immediately review your inventory for Catalog# 368656 with the lot numbers listed. Return all product subject to recall according to the Packing Instructions enclosed. 2. Identify all your customers that purchased affected lots of Catalog #368656, as listed . E-mail an excel file listing of all customers with their email addresses to BD6086@stericycle.com, within 72 hours of receipt of this letter so that BD may notify these customers directly. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted mate |
| Quantity | 1735600 units |
| Distribution | Worldwide distribution - US Nationwide distribution including the states of CT, FL, MO, TN, OH, TX, GA, NC, SC, IN, IL, PA, CO and countries of Trinidad and Tobago, Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011984 | BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET Becton, Dickinson & CO, Aug 29, 2001 |