PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 17, 2019 Initiated: March 7, 2019 #Z-1122-2019

Product Description

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.

Details

Units Affected
6,509,600
Distribution
US distribution to the states of FL and NJ.
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010. Recalled by Becton Dickinson & Company. Units affected: 6,509,600.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 17, 2019. Severity: Moderate. Recall number: Z-1122-2019.