Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81399

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

Open FDA event record

Event summary

Timeline bucket
September 05, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

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

Irrisept OR, Finished Bottle Assembly 450 ml STEP 1

Z-0490-2019
Recall number
Z-0490-2019
Initiated
September 05, 2017
Classification
Class II
Status
Terminated
Quantity
10,440

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Code information

Model # FB-A-400-107 Lot Number: 4J006

Distribution pattern

AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI