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BD Vacutainer Luer Lok Access Device - intended as a… recallZ-0665-2022 · Becton Dickinson & Company · initiated Jan 6, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0665-2022
Status
Open, Classified
Initiated by the company
Jan 6, 2022
Recalling firm
Becton Dickinson & Company
Quantity
288,152,790 Units
Product code
JKA
FDA submissions
K991088
Distribution
US Nationwide distribution in the state of IL.

Product 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

Code information (models, lots, serial numbers)

All Lots within Expiry Catalog No: 364902 UDI: (01)50382903649025 Catalog Number: 36490200 UDI:(01)60382903649022

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K991088 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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