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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.

FDA Recall Z-1746-2017 · Posted 2017-04-06

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2017-03-16
Date Terminated2018-05-01
Product Quantity13,064,500 tubes (non-expired)

Reason for Recall

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide - US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K945952VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBEBd Becton Dickinson Vacutainer Systems Preanalytic · 1995-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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