FDA Devices recall · Reported October 11, 2023
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
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Arrow International Inc. recalled Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded wit… - a critical-severity action.
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded wit… was recalled by Arrow International Inc. in October 11, 2023. Reason: This recall has been initiated due to reports that the product code and product name were incorrectly listed …. Check the official notice for the remedy. Verify recall #Z-0001-2024 with the FDA Devices before acting.
The recall
Arrow International Inc. issued this critical-severity FDA Devices recall-This recall has been initiated due to reports that the product code and product name were incorrectly listed ….
- Critical
- severity level
- 1K units
- affected scope
- Class I
- classification
- October 11, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0001-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0001-2024) was formally reported on October 11, 2023, with the manufacturer initiating the action on August 10, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Arrow International Inc. is listed as the recalling firm, operating out of Morrisville, NC. Federal records list the affected scope as 1173 units.
The documented reason for this recall is: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits. Distribution data in the federal record shows the product reached: US. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0001-2024 |
| Date reported | October 11, 2023 |
| Date initiated | August 10, 2023 |
| Recalling firm | Arrow International Inc. |
| Firm location | Morrisville, NC |
| Affected scope | 1173 units |
| Distribution | US |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0001-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Why was this product recalled? ▼
Which agency issued this recall? ▼
Where was the recalled product distributed? ▼
Should I stop using a recalled medication or medical device? ▼
Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… → · All Medical Devices recalls
Methodology · Corrections · Archive as of August 2026