—#175516

Product

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 retraction.

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K011984
Affected lot / code info: Lot / Serial Number. 9079767 9079770 9081829 9086811 9086812 9091607 9091626 9094659 9094661 9098547 9100711 9100712 9115965 9115913

Why it was recalled

Separation of front and rear barrels upon activation of the safety feature that retracts the needle

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 material so that BD may acknowledge your receipt of this notification and process your credit accordingly. Please note that this is in addition to providing the customer list For any question please contact Customer/Technical Support: 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT)

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2019-07-31
Terminated: 2020-07-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175516. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.