Becton Dickinson & Company: BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

Is my product affected?

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

• UPC 50885403235915

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company is recalling BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010, due to a defect in the luer component. The luer could break during use, potentially causing the device to leak or break off and become stuck in a fistula needle port, which would make the port inaccessible for dialysis treatment. Affected patients would then require re-cannulation with a new fistula needle to receive their dialysis treatment. Approximately 6.5 million units were distributed to Florida and New Jersey.

The recalled products were distributed with multiple lot numbers dated between March and July 2021, identified by specific UDI codes beginning with 18041501 through 18081501. The record does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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. Quantity: 6,509,600 Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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