Recall Z-2337-2017— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2017-05-09, terminated 2018-09-17. It names one FDA 510(k) clearance: K900263. Product: ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation. Reason: 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.
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-09
- Terminated
- 2018-09-17
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.