Z-1122-2019Class II

BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

Name: Z-1122-2019 BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Creator: Becton Dickinson & Company
Published: 2019-03-07
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-03-07 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 on 2019-03-07. FDA classified it as Class II and gives the reason as "The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1122-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Posted: 2019-04-10
Terminated: 2020-05-12
Recalling firm: Becton Dickinson & Co
Product: BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.
FDA root cause: Process change control
Action: Urgent Medical Device Recall notification letters dated 3/7/19 were distributed to customers.
Quantity in commerce: 6,509,600
Distribution: US distribution to the states of FL and NJ.
Product codes and lots: Lot Numbers, UDI: 18041501, (17)210315(10)18041501, (01)50885403235915. 18042501, (17)210325(10)18042501, (01)50885403235915. 18050501, (17)210405(10)18050501, (01)50885403235915. 18051501, (17)210415(10)18051501, (01)50885403235915. 18052501, (17)210425(10)18052501, (01)50885403235915. 18060501, (17)210505(10)18060501, (01)50885403235915. 18061501, (17)210515(10)18061501, (01)50885403235915. 18062501, (17)210525(10)18062501, (01)50885403235915. 18070501, (17)210605(10)18070501, (01)50885403235915. 18072501, (17)210625(10)18072501, (01)50885403235915. 18080501, (17)210705(10)18080501, (01)50885403235915. 18081501, (17)210715(10)18081501, (01)50885403235915.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1122-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1122-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-10

Product code JKA

K972404Class IVacutainer Brand Safety Blood Collection Assembly(multiple)Bd Becton Dickinson Vacutainer Systems Preanalytic / cleared 1997-07-22

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)