Recall Z-0837-2020— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2019-12-06, terminated 2021-11-02. It names one FDA 510(k) clearance: K163513. Product: Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH. Reason: Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-06
- Terminated
- 2021-11-02
- 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
Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Reason for recall
Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH.
Data sourced from openFDA. This site is unofficial and independent of the FDA.