FDA Recall Terminated

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.

Recall: Z-1746-2017 · Initiated March 16, 2017

Recall

Recall Number
Z-1746-2017
Event Number
76826
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
JKA
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
March 16, 2017
Posted
April 6, 2017
Terminated
May 1, 2018
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and processing blood in a closed tube. The buffered sodium citrate additive provides an anti-coagulated specimen that may be used for clinical laboratory coagulation assays and determinations.

Reason

BD is initiating this product correction of multiple lots of BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (13x75 mm x 4.5 mL). A limited number of tubes in these lots may exhibit stopper pullout from the tube as the user removes the needle from the stopper following specimen collection.

Action

BD sent an "Urgent Product Correction Letters and Customer Product Correction Response Forms" dated March 16, 2017 via email or UPS to their customers and distributors.

Distribution

Worldwide - US Nationwide Distribution

Quantity

13,064,500 tubes (non-expired)