FDA Recall Open, Classified

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.

Recall: Z-0745-2017 · Initiated August 8, 2016

Recall

Recall Number: Z-0745-2017
Event Number: 75252
Firm: Becton Dickinson & Company
FEI Number: 2243072
Product Code: JKA
Status: Open, Classified
Root Cause: Device Design
Initiated: August 8, 2016
Address: 1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

Reason

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.

Action

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 [email protected] (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 [email protected]. 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.

Distribution

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

Quantity

1,788,150 units