Z-1189-2017 Class II Terminated
FDA device recall Z-1189-2017 was initiated by Becton Dickinson & Company on January 16, 2017 and is designated Class II. Reason for recall: A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant. The recall status is terminated (terminated February 7, 2018). Affected quantity: 1,488,800 tubes.
Recall Details
- Product Type
- Devices
- Report Date
- February 22, 2017
- Initiation Date
- January 16, 2017
- Termination Date
- February 7, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,488,800 tubes
Product 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 for Recall
A portion of this lot of blood collection tubes was manufactured with approximately twice the expected amount of buffered sodium citrate additive, an anticoagulant.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Canada, Mexico, Indonesia
Code Information
Lot 6090572