CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report
AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow recalled
Arrow International is recalling AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are, distributed nationwide in the US. The recall was initiated on 20 Mar 2017 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-2279-2017
- FDA event ID
- 76937
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Mar 2017
- FDA classified
- 6 Jun 2017
- Reported
- 14 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 20 Mar 2017 | Recall initiated by company | |
| 6 Jun 2017 | Classified by FDA | +78 days |
| 14 Jun 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). The ARROWg+ard Blue PLUS¿ Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. The ARROWg+ard¿ technology is intended to provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSI's compared to the original ARROWg+ard Blue¿ catheter has not been studied
Where it was distributed
Nationwide Distribution
Questions about this recall
Is AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are recalled?
Yes. Arrow International recalled AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are on 20 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-2279-2017.
Why was it recalled?
Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.
Which lots are affected?
Material number CDA-42703-P1A
Where was it sold?
Nationwide Distribution
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.
More recalls from Arrow International
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|---|---|---|---|---|---|
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| Device | CLASS I | Description/REF: Hemodialysis KIT: 2-Lumen 8 FR X 11 CM/AK-11802-F recalled | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: PI CVC KIT recalled by Arrow International | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: PI Picc: 3: 6FR x 55CM w CHG/ Dlx-35563-Hpkc; Agba recalled | Arrow International | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Description/REF: Pacing PSI KIT: 6 FR/AI-06210-KS, Pacing PSI KIT recalled | Arrow International | Lead & Heavy Metals | Nationwide |
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