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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66541

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

Open FDA event record

Event summary

Timeline bucket
October 18, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intra Pump Infusion Systems

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

CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"

Z-0099-2015
Recall number
Z-0099-2015
Initiated
October 18, 2013
Classification
Class II
Status
Terminated
Quantity
25,440 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product has the potential to have a clear debris on the tip of the needle.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product has the potential to have a clear debris on the tip of the needle.

Code information

Product Code CRN20, lot numbers 14N02, 15E01, 15A02

Distribution pattern

Worldwide Distribution: US (nationwide) in states of CA, PA, MA, IL, OH and NY; and Internationally to Canada.