FDA Device recall Z-2007-2018
5Fr. Catheter Clamp with Fastener
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of 5Fr. Catheter Clamp with Fastener by Arrow International, citing product sterility may be compromised due to unsealed packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2007-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-11 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
Reason
Product sterility may be compromised due to unsealed packaging.
Identifiers
| code_info | Lot Numbers: 13F17A0198 13F17C0056 13F17D0135 13F17D0236 13F17F0075 13F17F0600 13F17G0179 13F17H0107 13F17H0367 13F17J0198 13F17K0212 |
|---|
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-2007-2018%22
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