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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90830

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

Open FDA event record

Event summary

Timeline bucket
September 01, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
B Braun Medical 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

Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

Z-0009-2023
Recall number
Z-0009-2023
Initiated
September 01, 2022
Classification
Class II
Status
Ongoing
Recalling firm
B Braun Medical Inc
Quantity
94,000 US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for leakage at the catheter hub.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for leakage at the catheter hub.

Code information

UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01 Apr 2027 22E30G8241 01 May 2027 22E30G8242 01 May 2027

Distribution pattern

Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada