FDA Advisory No. 2017-315
Voluntary Recall of BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube, 13 x 75mm x 2.0mL
All concerned healthcare professionals, establishments and the general public are hereby advised by the Food and Drug Administration (FDA) regarding the voluntary recall of BD Vacutainer K2 EDTA (K2E) (see photos of the product below) distributed by Metro Drug, Inc. BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube is used for the collection of venous blood.
Product Name : BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube
Specifications : 13 x 75mm x 2.0mL
Catalog Code : 367841
Lot. No. : 6279849
Intended Use : For the collection of venous blood
Packaging/Selling Unit : Shelf pack of 100 tubes/Case of 10 Shelf packs
Registration No. : DVR – 3711
BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube
(13 x 75mm x 2.0mL)
Recall Catalog (Ref) / Lot Identification Sample
The above-stated medical device products are being voluntary recalled by Becton Dickinson and Company (BD). BD has confirmed that a limited portion of the lot was manufactured with less than the required amount of K@EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and potential delay of treatment or misdiagnosis/mismanagement of treatment and serious complications, such as failure to detect thrombocytosis or postponing surgery.
Distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product.
Dissemination of the information to all concerned is requested.