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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82984

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

Open FDA event record

Event summary

Timeline bucket
May 17, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arrow International 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

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access

Z-0053-2020
Recall number
Z-0053-2020
Initiated
May 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
3,143

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
labeling error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.

Code information

Lot/Batch Numbers: 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507, 13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936, 13F18G0480

Distribution pattern

US Nationwide Distribution