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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91092

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

Open FDA event record

Event summary

Timeline bucket
September 03, 2020
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Allison 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

CarePoint 60 mL Syringe Without Needle, REF: 04-7560

Z-0478-2023
Recall number
Z-0478-2023
Initiated
September 03, 2020
Classification
Class II
Status
Completed
Recalling firm
Allison Medical, Inc.
Quantity
2,004 Boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.

Code information

UDI-DI: 00786227756059, REF/Lot: 04-7560/ 80522

Distribution pattern

US: IA, LA, MS, FL, PR; OUS: BARBADOS