Z-0837-2020 Class II Terminated
FDA device recall Z-0837-2020 was initiated by Arrow International Inc on December 6, 2019 and is designated Class II. Reason for recall: Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH. The recall status is terminated (terminated November 2, 2021). Affected quantity: 575.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2020
- Initiation Date
- December 6, 2019
- Termination Date
- November 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 575
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.
Distribution Pattern
US: FL
Code Information
REF: ASK-00820-FLH Manufacturing Lots: 13F19E0247, 13F19F0006, and 13F19G0433 Exp. Date: Aug. 2020 - Sep. 2020