CLASS I Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
Arrow MAC Two-Lumen Central Venous Access Kit fr use recalled
Arrow International is recalling Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - Catheters, distributed in Florida, Georgia, Kentucky, Ohio, Pennsylvania, West Virginia. The recall was initiated on 27 Oct 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0351-2023
- FDA event ID
- 91090
- Recalling firm
- Arrow International, Morrisville, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Oct 2022
- FDA classified
- 9 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 27 Oct 2022 | Recall initiated by company | |
| 9 Dec 2022 | Classified by FDA | +43 days |
| 21 Dec 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.
Product as listed by the FDA
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Where it was distributed
US Distributor in states of: FL, GA, KY, OH, PA and WV.
FloridaGeorgiaKentuckyOhioPennsylvaniaWest Virginia
Stores named: Walmart
Questions about this recall
Is Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - Catheters recalled?
Yes. Arrow International recalled Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - Catheters on 27 Oct 2022. The recall is Class I and its status is Terminated. Recall number Z-0351-2023.
Why was it recalled?
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.
Which lots are affected?
UDI/DI 10801902159448, Lot Number 13F22C0349
Where was it sold?
US Distributor in states of: FL, GA, KY, OH, PA and WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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