Z-1746-2017Class II

BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton...

Name: Z-1746-2017 BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton...
Creator: Becton Dickinson & Company
Published: 2017-03-16
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2017-03-16 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of 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... on 2017-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1746-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-16
Posted: 2017-04-06
Terminated: 2018-05-01
Recalling firm: Becton Dickinson & Co
Product: 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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 13,064,500 tubes (non-expired)
Distribution: Worldwide - US Nationwide Distribution
Product codes and lots: Catalog Number: 367716 - Lot numbers: 5251673 with expiry 3/31/2017; 6064542 with expiry 9/30/17; 6187520 with expiry 1/31/2018 and 6253669 with expiy 3/31/18 Catalog Number: 369714 - Lot numbers: 5272777 with expiry 4/30/17; 5336909 with expiry 6/30/17; 5357632 with expiry 7/31/17; 6040953 and 6064634 both with expiry 9/30/17; 6090572 with expiry 10/31/17; 6124932 with expiry 11/30/17; 6173983 with expiry 12/31/17; 6187600 with expiry 1/31/18 and 6216656 with expiry 2/28/18 Lot numbers 6064542, 6187520 and 6253669 - limited to distribution outside the U.S. market. UDI for lot 6253669 is DI (01)30382903677161, PI (17)180331(10)6253669(30)0100 and lot 6216656 is DI (01)30382903697145, PI (17)180228(10)6216656(30)0100; for all other lots UDI is not applicable based on manufacture date.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1746-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1746-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-12	2017-04-06

Product code JKA

K945952Class IIVacutainer(r) Brand Plus Pst(tm) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1995-01-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)