FDA-Device2019-04-17Class II

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

Becton Dickinson & Company
Hazard

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.

Sold states
US distribution to the states of FL and NJ.
Affected count
6,509,600
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

Official notice

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

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