BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device

FDA device recall Z-1923-2013 · posted 2013-08-07 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

BD Vacutainer Multiple Sample and Direct Draw Luer Adapter may have blood leakage and low draw volume.

Action taken

BD sent a Product Advisory Notice dated May 3, 2013, via UPS to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard filled tubes since it is possible they will contain less blood volume (low draws), replace the Luer Adaptor unit being used with a fresh unit, and continue to draw blood samples using the fresh unit. Customers with questions were instructed to contact BD Technical Service at 1-800-631-0174, Option 4, or contact them through website: www.bd.com/vacutainer/contact. For questions regarding this recall call 201-847-6800.

Root cause

Under Investigation by firm

Status

Terminated

Product code

JKA

Quantity affected

37,906,400 units

Distribution

Nationwide Distribution

Date initiated

2013-05-01

Date posted

2013-08-07

Date terminated

2015-12-04

Location

Franklin Lakes, NJ