Exact FDA event identifier

Event 86423

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, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Medline Industries 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

ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airways. Single use only.

Z-0058-2021

Recall number: Z-0058-2021
Initiated: September 01, 2020
Classification: Class II
Status: Terminated
Recalling firm: Medline Industries Inc
Quantity: 6225 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There have been reports of the suction catheter coming apart from the device assembly during use.

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

There have been reports of the suction catheter coming apart from the device assembly during use.

Code information

Model: DYNCPDS14T, Lots 06919010016 and 06919020016

Distribution pattern

62 US consignees; 1 government consignee, 4 foreign consignees