FDA recall Z-1122-2019

Product

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

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.

Distribution

US distribution to the states of FL and NJ.

Key facts

Status

Terminated

Initiation date

2019-03-07

Report date

2019-04-17

Termination date

2020-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1122-2019