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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86680

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

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Event summary

Timeline bucket
March 23, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Janus Trade Group

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

B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01

Z-0509-2021
Recall number
Z-0509-2021
Initiated
March 23, 2020
Classification
Class II
Status
Terminated
Recalling firm
Janus Trade Group
Quantity
1365 cases (200 units/case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Distribution of B.Braun Introcan Safety IV catheters without a 510(k) within the United States by JTG.

Code information

Lots 18L23G8271 17A20G8273 18M02G8315 16H16G8261 18K18G8244 17D08G8241 16H16G8261 15H25G8315 18G15A272 18G31G8316 18G31G8392 17H20G8391 18M02G8315 18M02G8315 18F29G8362 18D01G8273 17K08G8272 17K08G8273 17G10G8261 19A12G8272 19A12G8272 18H17G8272 18H17G8272 18F26G8303 18H04G8261 15F25G8395 17K27G8304 17C16G8304 17H02G8392 17F15G8302 17M10G8271 17M10G8273 17M15G8261 17C17G8302 17C18G8305 18M20G8271 18L29G8271 18K08G8263 18HI8G8243 18F25G8272 18F25G8272 17M11G8273 17H23G8272 17H23G8271 17H23G8271 18L23G8271 18L23G8271 17A20G8273 17A20G873 17A20G8273 17D08G8241 17D08G8241 17D08G8241 16N24G8303 16H30G8303 16H30G8304 16L0G8275 14N10G8274 16H16G8261

Distribution pattern

US distribution to distributors located in CA, FL, IL, KS, NJ, NY, and TN.

Field note

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