FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
- Recall number
- Z-1122-2019
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
- Status
- Terminated
- Initiated
- 2019-03-07
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- 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.
- Root cause
- Process change control
- Action
- Urgent Medical Device Recall notification letters dated 3/7/19 were distributed to customers.
- Quantity
- 6,509,600
- Distribution
- US distribution to the states of FL and NJ.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K972404"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28