Exact FDA event identifier

Event 89795

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

Open FDA event record

Event summary

Timeline bucket: March 04, 2022
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: MEDLINE INDUSTRIES, LP - Northfield

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

Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.

Z-0898-2022

Recall number: Z-0898-2022
Initiated: March 04, 2022
Classification: Class II
Status: Terminated
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 7,800 pouched syringes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

Code information

Lot #3139133, Exp. 11/01/2022.

Distribution pattern

US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution.