Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69249

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

Open FDA event record

Event summary

Timeline bucket
August 14, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomedix, 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

Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿ and LDPE/PET pouch. Secondary packaging includes 48 pouched units per box/case. STERILE

Z-0023-2015
Recall number
Z-0023-2015
Initiated
August 14, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biomedix, Inc.
Quantity
2,928

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.

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

Customer contacted Biomedix of complaint and returned the failed set along with 86 units of unopened stock (96 units originally shipped). Biomedix performed extensive investigation and found insufficient application of glue. Recall was initiated due to the rate of the failure.

Code information

Model/Product Number: B30-102 Lot #416130 Exp. 12/2016

Distribution pattern

US Distribution including the states of OH, NC, and TX