Recall events
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Event 93014
Event summary
Timeline bucket August 10, 2023
Product types Device
Classifications Class I
Statuses Ongoing
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 ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0001-2024
Recall number Z-0001-2024
Initiated August 10, 2023
Classification Class I
Status Ongoing
Quantity 1173 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0001-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33876]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Code information Batch/Lot number 33F23B0781
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36787]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 4
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0002-2024
Recall number Z-0002-2024
Initiated August 10, 2023
Classification Class I
Status Ongoing
Quantity 180 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0002-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33878]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Code information Batch/Lot number 33F23B0723
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[36816]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 4
Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024
Recall number Z-0003-2024
Initiated August 10, 2023
Classification Class I
Status Ongoing
Quantity 380 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0003-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46310]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Code information Batch/Lot number 13F22L0806
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34323]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 4
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0004-2024
Recall number Z-0004-2024
Initiated August 10, 2023
Classification Class I
Status Ongoing
Quantity 172 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0004-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46309]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Code information Batch/Lot number 13F22G0508
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[34504]
FDA event record
· Exact recall-number query on openFDA
