Z-0058-2020Class II

BD Microtainer SST- Amber Part/Catalog Number: 365978

Name: Z-0058-2020 BD Microtainer SST- Amber Part/Catalog Number: 365978
Creator: Becton Dickinson & Company
Published: 2019-05-13
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-05-13 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Company began a recall of BD Microtainer SST- Amber Part/Catalog Number: 365978 on 2019-05-13. FDA classified it as Class II and gives the reason as "Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results". 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-0058-2020
Classification: Class II
Status: Terminated
Initiated: 2019-05-13
Posted: 2019-10-07
Terminated: 2020-08-06
Recalling firm: Becton Dickinson & Co
Product: BD Microtainer SST- Amber Part/Catalog Number: 365978
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Becton Dickinson (BD) notified consignees affected by letter via UPS and email dated May 13,2019. Letter describes reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific catalog and lot numbers listed below, 2. Destroy all product subject to the recall following your institution's process for destruction, 3. Share this Urgent Medical Device Recall notification with all users of the product to ensure that they are also aware of this recall, and 4. Complete the attached Customer Response/Certificate of Destruction Forms 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. Distributors provide their customer list to BD. BD PAS will notify these customers via mail. BD Contact US Contact Information Customer/Technical Support 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT).
Distribution: Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Product codes and lots: Lot Number/UDI: 8193502 (01)30382903659785 (17)190930(10)8193502(30)50 (17)190930(10)8193502(30)200(01)50382903659789 8193507 (01)30382903659785 (17)190930(10)8193507(30)50 (17)190930(10)8193507(30)200(01)50382903659789 8193511 (01)30382903659785 (17)190930(10)8193511(30)50 (17)190930(10)8193511(30)200(01)50382903659789 8204927 (01)30382903659785 (17)190930(10)8204927(30)50 (17)190930(10)8204927(30)200(01)50382903659789 8205758 (01)30382903659785 (17)190930(10)8205758(30)50 (17)190930(10)8205758(30)200(01)50382903659789 8207774 (01)30382903659785 (17)190930(10)8207774(30)50 (17)190930(10)8207774(30)200(01)50382903659789 8208542 (01)30382903659785 (17)190930(10)8208542(30)50 (17)190930(10)8208542(30)200(01)50382903659789 8208544 (01)30382903659785 (17)190930(10)8208544(30)50 (17)190930(10)8208544(30)200(01)50382903659789 8232513 "(01)30382903659785 (17)191031(10)8232513(30)50 (17)191031(10)8232513(30)200(01)50382903659789 8233967 (01)30382903659785 (17)191031(10)8233967(30)50 (17)191031(10)8236756(30)200(01)50382903659789 8236755 (01)30382903659785 (17)191031(10)8236755(30)50 (17)191031(10)8236755(30)200(01)50382903659789 8236756 (01)30382903659785 (17)191031(10)8236756(30)50 (17)191031(10)8233967(30)200(01)50382903659789 8239857 (01)30382903659785 (17)191031(10)8239857(30)50 (17)191031(10)8239857(30)200(01)50382903659789 8260948 (01)30382903659785 (17)191130(10)8260948(30)50 (17)191130(10)8260948(30)200(01)50382903659789 8262866 (01)30382903659785 (17)191130(10)8262866(30)50 (17)191130(10)8262866(30)200(01)50382903659789 8282812 (01)30382903659792 (17)191231(10)8282812(30)50 (17)191231(10)8282812(30)200(01)50382903659796"

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0058-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0054-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07
Z-0055-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07
Z-0056-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07
Z-0057-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07
Z-0058-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07
Z-0059-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07
Z-0060-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07
Z-0061-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-07

Product code JKA

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)