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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94896

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

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Event summary

Timeline bucket
June 26, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Becton Dickinson Infusion Therapy Systems, Inc.

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.

How coverage and grouping work

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 Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. BD Insyte Autoguard BC Shielded IV Catheter is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.

Z-2458-2024
Recall number
Z-2458-2024
Initiated
June 26, 2024
Classification
Class II
Status
Ongoing
Quantity
26,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.

Code information

Lot # 4127714/ UDI-DI: 00382903825332

Distribution pattern

US: IL OUS: N/A0