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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- Becton Dickinson & Company
- 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
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