CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report
ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are recalled
Arrow International is recalling ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to, distributed nationwide in the US. The recall was initiated on 9 May 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-2337-2017
- FDA event ID
- 77232
- Recalling firm
- Arrow International, Reading, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 May 2017
- FDA classified
- 12 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 9 May 2017 | Recall initiated by company | |
| 12 Jun 2017 | Classified by FDA | +34 days |
| 21 Jun 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
Product as listed by the FDA
ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
Where it was distributed
Worldwide Distribution - US (nationwide) and Canada
Questions about this recall
Is ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to recalled?
Yes. Arrow International recalled ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to on 9 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2337-2017.
Why was it recalled?
The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access
Which lots are affected?
Material number: CDC-24301-1A, CDC-24306-1A Device Listing D025398
Where was it sold?
Worldwide Distribution - US (nationwide) and Canada
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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