Z-0193-2020Class II

BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 -

Name: Z-0193-2020 BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 -
Creator: Becton Dickinson & Company
Published: 2019-07-31
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-07-31 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an... on 2019-07-31. FDA classified it as Class II and gives the reason as "Separation of front and rear barrels upon activation of the safety feature that retracts the needle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0193-2020
Classification: Class II
Status: Terminated
Initiated: 2019-07-31
Posted: 2019-10-24
Terminated: 2020-07-27
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder Catalog number 368356 - Product Usage: This product is designed to provide customers an increased level of safety during IV blood collection, convenience and to improve OSHA single-use holder compliance. Figure 1 shows a BD Vacutainer Push Button Blood Collection Set with the needle protector removed prior to needle retraction.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Separation of front and rear barrels upon activation of the safety feature that retracts the needle
FDA root cause: Under Investigation by firm
Action: 1. Immediately review your inventory for Catalog# 368656 with the lot numbers listed. Return all product subject to recall according to the Packing Instructions enclosed. 2. Identify all your customers that purchased affected lots of Catalog #368656, as listed . E-mail an excel file listing of all customers with their email addresses to [email protected], within 72 hours of receipt of this letter so that BD may notify these customers directly. 3. Complete the attached Distributor 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 credit accordingly. Please note that this is in addition to providing the customer list For any question please contact Customer/Technical Support: 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT)
Quantity in commerce: 1735600 units
Distribution: Worldwide distribution - US Nationwide distribution including the states of CT, FL, MO, TN, OH, TX, GA, NC, SC, IN, IL, PA, CO and countries of Trinidad and Tobago, Hong Kong.
Product codes and lots: Lot / Serial Number. 9079767 9079770 9081829 9086811 9086812 9091607 9091626 9094659 9094661 9098547 9100711 9100712 9115965 9115913

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0193-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0193-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24

Product code FMI

K011984Class IIBd Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO / cleared 2001-08-29

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)