FDA Recall Terminated

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 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-1189-2017 · Initiated January 16, 2017

Recall

Recall Number
Z-1189-2017
Event Number
76295
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
JKA
Status
Terminated
Root Cause
Process control
Initiated
January 16, 2017
Terminated
February 7, 2018
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 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

A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.

Action

BD sent an Urgent Product Recall letter dated January 16, 2017 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Recall Response Form and fax the completed form back to BD at 1-844-388-5534 or email the completed form to [email protected]. For questions call 1-844-265-7408.

Distribution

Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia

Quantity

1,488,800 tubes