FDA Device recall Z-1332-2018
(1) Access Tray, Part Number (PN): ASK-04001-MS
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of (1) Access Tray, Part Number (PN): ASK-04001-MS 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-1332-2018 |
| 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
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
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) 13F17E0546; (2) 13F16L0177, 13F17E0449, 13F17E0873, 13F17F0295; (3) 13F17E0677, 13F17F0477; (4) 13F17A…Lot Numbers: (1) 13F17E0546; (2) 13F16L0177, 13F17E0449, 13F17E0873, 13F17F0295; (3) 13F17E0677, 13F17F0477; (4) 13F17A0318, 13F17F0083; (5) 13F16M0272, 13F17E0648; (6) 13F17B0122, 13F17F0512; (7) 13F17A0320, 13F17F0528 |
|---|
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-1332-2018%22
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