FDA Enforcement
Class II
Terminated
Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
Recall: Z-0837-2020
·
Reported January 29, 2020
Enforcement
- Recall Number
- Z-0837-2020
- Event ID
- 84520
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 29, 2020
- Initiation Date
- December 6, 2019
- Classification Date
- January 22, 2020
- Termination Date
- November 2, 2021
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607, United States
Description
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.
Code Info
REF: ASK-00820-FLH Manufacturing Lots: 13F19E0247, 13F19F0006, and 13F19G0433 Exp. Date: Aug. 2020 - Sep. 2020
Distribution
US: FL
Quantity
575