FDA Device recall Z-1333-2018
ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of ARROWg+ard Blue¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A 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-1333-2018 |
| 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¿ CVC Kit (1) Part Number (PN): CDC-24301-1A, (2) PN: CDC-24306-1A; (3) ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit, PN: CDC-22123-1A; (4) Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions, PN: ASK-24301-GM; (5) Hemodialysis Catheterization Kit for High Volume Infusions, PN: CDC-25123-1A
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) 13F17B0345, 13F17E0644, 13F17E0871, 13F17F0291; (2) 13F17B0124, 13F17B0355, 13F17E0727; (3) 13F16M0266…Lot Numbers: (1) 13F17B0345, 13F17E0644, 13F17E0871, 13F17F0291; (2) 13F17B0124, 13F17B0355, 13F17E0727; (3) 13F16M0266, 13F17C0484, 13F17E0798; (4) 13F17B0037, 13F17E0451; (5) 13F17A0017, 13F17A0314, 13F17D0060, 13F17E0799, 13F17F0489 |
|---|
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-1333-2018%22
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