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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90725

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

Open FDA event record

Event summary

Timeline bucket
August 10, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Saranas, 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

Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)

Z-1684-2022
Recall number
Z-1684-2022
Initiated
August 10, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Saranas, Inc.
Quantity
953

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.

Code information

UDI/REF/Lot: 00866532000402/FG001-01/510090S, 511110A, 510120F, 102422, 102445, 102531, 102671, 102685, 102731; 00866532000419/FG001-02/515070A, 528090C, 510120G, 511110B, 102567, 102610, 102611

Distribution pattern

US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ, GA, LA, NY, MA, CT, AZ, OH, TN, VA.