FDA Device recall Z-1848-2020
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)0060791…
- FDA Device
- Class I
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class I recall of Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)0060791… by Applied Medical Resources, citing the firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1848-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-10-24 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Applied Medical Resources |
| Distribution | US |
Product
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
Reason
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
Identifiers
| code_info | Model A4GW6, Applied Medical DUAL LUMEN GRAFT CLEANING CATETER, 9mm X 60cm, lot numbers 1267676, 1272322, 1284680, 1295…Model A4GW6, Applied Medical DUAL LUMEN GRAFT CLEANING CATETER, 9mm X 60cm, lot numbers 1267676, 1272322, 1284680, 1295323, 1306127, 1312586, 1330450, 1334826, 1338738, 1339555 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1848-2020%22
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