Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81607

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

Open FDA event record

Event summary

Timeline bucket
November 05, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
COVIDIEN LLC

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

8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826

Z-0656-2019
Recall number
Z-0656-2019
Initiated
November 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
COVIDIEN LLC
Quantity
32,071 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product was released into commercial distribution while subject to importation refusal.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product was released into commercial distribution while subject to importation refusal.

Code information

Lot Number 1816211264

Distribution pattern

The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.