FDA Device recall Z-2771-2016
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days
- FDA Device
- Class II
- terminated
- Published 2016-09-21
On 2016-09-21 the FDA classified a Class II recall of Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days by Arrow International, citing notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2771-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-17 |
| Published | 2016-09-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | FL, MD, NC, OH |
Product
Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
Reason
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Identifiers
| code_info | Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H103…Lot/Batch Numbers: 23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2771-2016%22
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