CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report
Arrow AGB+ Multi-Lumen CVC Kit 3 Lumen- Intended recalled
Arrow International is recalling Arrow AGB+ Multi-Lumen CVC Kit 3 Lumen- Intended for venous access to the central, distributed nationwide in the US. The recall was initiated on 6 Jan 2021 and the FDA has classified it as Class II.
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-1106-2021
- FDA event ID
- 87092
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jan 2021
- FDA classified
- 10 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 6 Jan 2021 | Recall initiated by company | |
| 10 Feb 2021 | Classified by FDA | +35 days |
| 17 Feb 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction
Product as listed by the FDA
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Where it was distributed
US Nationwide
Questions about this recall
Is Arrow AGB+ Multi-Lumen CVC Kit 3 Lumen- Intended for venous access to the central recalled?
Yes. Arrow International recalled Arrow AGB+ Multi-Lumen CVC Kit 3 Lumen- Intended for venous access to the central on 6 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1106-2021.
Why was it recalled?
The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction
Which lots are affected?
Lot Code: 13F20E0173
Where was it sold?
US Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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