FDA Device recall Z-1228-2017
Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intraven…
- FDA Device
- Class II
- terminated
- Published 2017-03-01
On 2017-03-01 the FDA classified a Class II recall of Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intraven… by Arrow International, citing there have been complaints for peel away sheaths flaring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1228-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-11 |
| Published | 2017-03-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
Reason
There have been complaints for peel away sheaths flaring
Identifiers
| code_info | Material # ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552…Material # ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552-LS5, PI-01552-SS, PL-05041, PL-05041, PL-05052, PR-05041, PR-05041, PR-05041-T, PR-05042, ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01351-SS, PI-01451-LS, PI-01451-LS5, PI-01451-SS, PI-01451-SS, PI-0-1552-LS |
|---|
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-1228-2017%22
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