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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81040

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
August 23, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton Dickinson & Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shielding mechanism that is activated as part of the usual insertion procedure when the needle is withdrawn from the catheter. BD Nexiva device is designed to protect the clinician from accidental needle stick injuries and minimize exposure to blood during the insertion process. The needle shield is designed to not release from the catheter adapter until the needle tip is protected and cannot be rearmed once activated. The BD Nexiva device is intended for use in the peripheral vascular system to provide access for the administration of fluids, medication, blood and blood products, and for the withdrawal of blood samples. This catheter may be used for any patient population with consideration given to patient size, appropriateness for solutions being infused and duration of therapy.

Z-0384-2019
Recall number
Z-0384-2019
Initiated
August 23, 2018
Classification
Class II
Status
Terminated
Quantity
133,230 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

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Inspect official wording and provenance

Reason for recall

One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated needlestick injury.

Code information

Lot 8087800, UDI (01)30382903835394

Distribution pattern

Worldwide Distribution -US Nationwide in the states of: CA, CO, FL, GA, IL, LA, MI, ND, NE, NY, OH, PA, RI, SC, VA, WA and WV. The products were distributed to the following foreign countries: Argentina, Australia, Belgium, Brazil, Canada, Colombia, Costa Rica, Mexico and New Zealand.