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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77589

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

Open FDA event record

Event summary

Timeline bucket
June 01, 2017
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

4 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 4

Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

Z-0179-2018
Recall number
Z-0179-2018
Initiated
June 01, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Code information

Lot/Batch Numbers: 23F16M0017

Distribution pattern

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

device · product 2 of 4

ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Z-0180-2018
Recall number
Z-0180-2018
Initiated
June 01, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Code information

Lot/Batch Number: 23F16M0263

Distribution pattern

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

device · product 3 of 4

ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Z-0181-2018
Recall number
Z-0181-2018
Initiated
June 01, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Code information

Lot/Batch Number: 23F16K0055

Distribution pattern

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

device · product 4 of 4

ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Z-0182-2018
Recall number
Z-0182-2018
Initiated
June 01, 2017
Classification
Class II
Status
Terminated
Recalling firm
Arrow International Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths.

Code information

Lot/Batch Number: 23F16L0021

Distribution pattern

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

Field note

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