Exact FDA event identifier

Event 80682

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: July 10, 2018
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

2 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 2

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14702 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.

Z-2818-2018

Recall number: Z-2818-2018
Initiated: July 10, 2018
Classification: Class II
Status: Terminated
Recalling firm: Arrow International Inc
Quantity: 7024 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

packaging may not be sealed. If the packaging is compromised

Sterility assurance reason.sterility_assurance · v1.0.0

packaging may not be sealed. If the packaging is compromised in this manner, the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

Code information

14F15F0156, 14F15H0228, 14F15K0746, 14F16B0085, 14F16D0424, 14F16F0700, 14F16G0471

Distribution pattern

Worldwide Distribution: US (nationwide) to the following states of: AK, AL, CA, FL, HI, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NY, OH, OR, PA, SC, SD, TX, WI, and WV; to countries of:: Finland, Germany, Hungary, Netherlands, South Africa, United Arab Emirates and the United Kingdom.

device · product 2 of 2

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.

Z-2819-2018

Recall number: Z-2819-2018
Initiated: July 10, 2018
Classification: Class II
Status: Terminated
Recalling firm: Arrow International Inc
Quantity: 5507 units