—#149793

Product

BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K030573
Affected lot / code info: 5355531 5355533 5356681 5356682 6006629 6006630 6006631 6006633 6006634 6006650

Why it was recalled

BD has received multiple reports of units associated with the 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing whose lots are exhibiting separation of front and rear barrels upon activation of the safety feature, which retracts the needle.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, BD, sent a "URGENT PRODUCT RECALL" letter dated 8/8/2016 to its customer with a return response form via UPS 2nd Day mail on 8/8/2016.The letter described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory for the specific lot numbers, quarantine the product and discontinue the shipment of the affected product; complete and return the Recall Response Form by fax to BD at 1-866-913-0661 or email to bd6835@stericycle.com (even if you do not have any product); return all affected products with completed response form per packing instructions; if you have distributed this product, identify your customers and notify them immediately of this product recall; if you would like BD to conduct the notification to your customers, email your customer list within 3 business days to Matthew.Kelleher@bd.com. if you have any questions or require assistance with the return of the recalled product and/or availability of credit product, contact 1-888-628-0732 between 8Am and 5 PM ET Monday through Friday.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution- US (nationwide) and countries of: Canada, Belgium, Brazil.

Timeline

Recall initiated: 2016-08-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #149793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.