Food, drugs, devices › ARROW INTERNATIONAL Inc.
Device recall: Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, R
ARROW INTERNATIONAL Inc. (Morrisville, NC) initiated this device recall on 10 Aug 2023; FDA lists 4 product records under event 93014, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 10% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. ARROW INTERNATIONAL Inc. has 93 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ARROW INTERNATIONAL Inc., Morrisville, NC.
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."
Distribution
"US"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0001-2024 | 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 | 1173 units | Class I | Ongoing | 11 Oct 2023 |
| Z-0002-2024 | 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 | 180 units | Class I | Ongoing | 11 Oct 2023 |
| Z-0003-2024 | Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days | 380 units | Class I | Ongoing | 11 Oct 2023 |
| Z-0004-2024 | 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 | 172 units | Class I | Ongoing | 11 Oct 2023 |
Context
Other enforcement events for ARROW INTERNATIONAL Inc.
All 93 events for ARROW INTERNATIONAL Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.