The Recall Desk
HighFDA (Devices)·Z-1122-2019·Announced 2019-04-17

BD Blood Collection Assembly Recalled for Luer Breakage Risk

Becton Dickinson is recalling 6.5 million blood collection assemblies because the luer could break, causing leaks or blocking dialysis ports.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inaccessible dialysis port requiring re-cannulation) without reported injuries or deaths in the source text.

Plain-English summary

Becton Dickinson & Company is recalling 6,509,600 units of BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010. The affected units were distributed in the United States to the states of Florida and New Jersey.

The recall was initiated because the luer component of the device could break. This failure could cause the device to leak or break off, potentially getting stuck in the fistula needle port. If this occurs, the port becomes inaccessible for dialysis, requiring the patient to be re-cannulated with a new fistula needle to receive treatment.

Patients and healthcare providers should check their devices for the specific lot numbers and UDI codes listed in the official recall notice. If a device is affected, it should be stopped from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Affected units
6,509,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 2 states: