FDA Device recall Z-1298-2018
ArrowClarke" PleuraSeal¿ Thoracentesis Kit
- FDA Device
- Class II
- terminated
- Published 2018-04-11
On 2018-04-11 the FDA classified a Class II recall of ArrowClarke" PleuraSeal¿ Thoracentesis Kit by Arrow International, citing product packaging may not be completely sealed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1298-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-24 |
| Published | 2018-04-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | n/a |
Product
ArrowClarke" PleuraSeal¿ Thoracentesis Kit
Reason
Product packaging may not be completely sealed.
Identifiers
| code_info | AK01000 AK-01000-J AK-01000-T ASK-01000-CHP |
|---|
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-1298-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.