Exact FDA event identifier

Event 90964

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

Open FDA event record

Event summary

Timeline bucket: September 14, 2022
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

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

Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory

Z-0195-2023

Recall number: Z-0195-2023
Initiated: September 14, 2022
Classification: Class II
Status: Terminated
Recalling firm: Avanos Medical, Inc.
Quantity: 1378 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sterile extension sets were distributed without an expiration date

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Incorrect or no expiration date

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile extension sets were distributed without an expiration date

Code information

ALL LOT CODES

Distribution pattern

US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI