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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92970

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

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Event summary

Timeline bucket
August 29, 2023
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

REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

Z-0025-2024
Recall number
Z-0025-2024
Initiated
August 29, 2023
Classification
Class II
Status
Ongoing
Quantity
98,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.

Code information

Lot # 2238464/ UDI-DI: (01)00382903868629

Distribution pattern

US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.