FDA Enforcement
Class III
Ongoing
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200
Recall: Z-0665-2022
·
Reported March 2, 2022
Enforcement
- Recall Number
- Z-0665-2022
- Event ID
- 89486
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- March 2, 2022
- Initiation Date
- January 6, 2022
- Classification Date
- February 23, 2022
- Address
- 1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States
Description
BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 36490200
Reason
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
Code Info
All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022
Distribution
US Nationwide distribution in the state of IL.
Quantity
288,152,790 Units