Recall Z-0837-2020 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Arrow Endurance" Extended Dwell Peripheral Catheter System, REF: ASK-00820-FLH
| Date | Dec 6, 2019 |
| Status | Terminated |
| Reason | Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH. |
| Root cause | Employee error |
| Action | On December 6, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: Urgent Medical Device Recall Notice Arrow Endurance" Extended Dwell Peripheral Catheter System EIF-000391 December 06, 2019 To: Customer of Arrow Products Arrow International is voluntarily recalling the following product code and lots: Product Code: ASK-00820-FLH Lot Numbers: 13F19E0247, 13F19F0006, 13F19G0433 Arrow International is recalling the above product code and lots due to a potential sterility issue. The product was processed through the incorrect sterilization cycle; thus, |
| Quantity | 575 |
| Distribution | US: FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Feb 24, 2017 |