BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer tubes are used to collect, t

FDA device recall Z-0456-2016 · posted 2015-12-21 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some cases to blood splatter or spraying.

Action taken

BD sent an "Urgent Product Recall notifications/Recall Response Forms dated November 17, 2015 via email and/or UPS Next Day Mail on November 17, 2015 to their customers. The notification identifies the affected product and problem and actions to be taken. Customers are requested to take the following actions (1) Immediately review their inventory and quarantine the product subject to the recall and immediately discontinue the shipment of the affected product (2) complete the enclosed Recall Response Firm and fax it bat to BD at 1.866.873.0312 or emai to bd8554@stericycle.com (3) Return all affected products with the completed Recall Response Form following the instruction on the enclosed packing instruction and (5) if distributed, identify your customers and notify them immediately of this product recall. If the customers had any questions, they were instructed to contact BD at 1.888.628.0732 between 8 AM and 5 PM Monday through Friday.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JKA

Quantity affected

4,835,000 units

Distribution

Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.

Date initiated

2015-11-17

Date posted

2015-12-21

Date terminated

2016-06-08

Location

Franklin Lakes, NJ

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