Exact FDA event identifier

Event 84021

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: October 08, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Avanos Medical, 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

2 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 2

CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.

Z-0370-2020

Recall number: Z-0370-2020
Initiated: October 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Avanos Medical, Inc.
Quantity: 104 cases (208 units) total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The connector piece to the PEG tube does not pass over the guidewire.

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 connector piece to the PEG tube does not pass over the guidewire.

Code information

Catalog Number: 30-4020 (Lot Numbers:0203145253, 0203081127); Catalog Number: 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065)

Distribution pattern

Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.

device · product 2 of 2

CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit with ENFit Connector. 2 units per case The devices could be branded as Halyard Health.

Z-0371-2020

Recall number: Z-0371-2020
Initiated: October 08, 2019
Classification: Class II
Status: Terminated
Recalling firm: Avanos Medical, Inc.
Quantity: 104 cases (208 units) total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The connector piece to the PEG tube does not pass over the guidewire.

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 connector piece to the PEG tube does not pass over the guidewire.

Code information

Catalog Number: 50-4016E1 (Lot Numbers:0203137961, 0203172166); Catalog Number: 50-4020E1 (Lot Number: 0203069043)

Distribution pattern

Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.