FDA Device recall Z-1336-2018
ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A by Arrow International, citing certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1336-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-22 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | DC |
Product
ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
Reason
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Identifiers
| code_info | Lot Numbers: (1) 13F16M0268, 13F17C0395, 13F17E0158, 13F17E0536; (2) 13F17A0254; (3) 13F16M0233, 13F17D0190; (4) 13F17B0137, 13F17D0225 |
|---|
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-1336-2018%22
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