Class 3 Device Recall BD

• Date Initiated by Firm: January 06, 2022
• Create Date: February 23, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0665-2022
• Recall Event ID: 89486
• 510(K)Number: K991088
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: 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
• Code Information: All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: SAME; 201-847-6800
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Under Investigation by firm
• Action: BD issued Urgent Medical Device Correction letter via email to Sysmex on January 06, 2022, requesting they inform/distribute to their customers still using a Sysmex UF-1000i or UX-2000 analyzer the notification provided by BD .The scope would include any customers who were shipped Vacutainer LLAD products still using a Sysmex UF-1000i or UX-2000 analyzer. Sysmex issued letter to their customers addressed to the Urinalysis Manager instructs the customer to respond to Sysmex. 1. Sysmex customers should retain a copy of this notification and post near your analyzer as a visual reminder of this potential issue. 2. Complete the Notification Response Form to confirm receipt of this medical device correction. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program. 1. BD is updating the IFU for the LLAD products to include a precaution to confirm any abnormal urinalysis results per facility policy/procedure and best practices and that BD Vacutainer¿ LLAD devices are not recommended for use with Sysmex UF-1000i and UX- 2000 analyzers as it may falsely identify contaminant particles as Red Blood Cells. BD will notify Sysmex via follow-up communication when these revisions are completed (anticipated by June 2022). 2. BD continues to investigate the root cause of this issue and will apply corrective actions as appropriate. Sysmex will be notified if any additional actions are required upon completion of the root cause analysis. Product will continue to ship so as not to impact critical patient care.
• Quantity in Commerce: 288,152,790 Units
• Distribution: US Nationwide distribution in the state of IL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JKA and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS