Z-2055-2018Class II

BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983

Name: Z-2055-2018 BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
Creator: Becton Dickinson & Company
Published: 2018-02-13
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-02-13 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983 on 2018-02-13. FDA classified it as Class II and gives the reason as "Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube". 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-2055-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-13
Posted: 2018-06-01
Terminated: 2020-03-09
Recalling firm: Becton Dickinson & Co
Product: BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On March 15, 2018 BD Life Sciences sent Urgent Medical Device Recall Notifications to affected customers. Customers were instructed to : 1. Immediately review your inventory for the subject lots and quarantine the product subject to the recall. 2. Share this recall notification with all users of the product to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Return all affected products using the enclosed packaging instructions and include the completed Recall Response Form with the product. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. Web: Medwatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088); Mail: MedWatch, HF-2, FDA 5600 Fisher's Lane, Rockville, MD 20853-9787. Customer who require further assistance should contact BD Preanalytical Systems at (877)870-4486, Mon-Fri 8:00am-5:00pm
Quantity in commerce: 9,568,900 total products
Distribution: US Nationwide, Argentina, Belize , Brazil, Canada, China, Guam, India, Japan, Mexico, Nicaragua, Pakistan, Philippines, Singapore, Suriname, Taiwan
Product codes and lots: 1) UDI DI (01)50382903679831 PI (17)180531(10)7135828(30)1000 Lot/Serial # 7315828 Exp Date 5/31/2018 2) UDI DI (01)50382903679831 PI (17)180531(10)7146901(30)1000 Lot/Serial # 7125692 Exp Date 4/30/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2055-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2055-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-01
Z-2056-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-01

Product code JKA

K023075Class IIBd Vacutainer Plus Sst Serum Separator TubeBd Vacutainer Systems Preanalyical Solutions / cleared 2002-11-25

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)