FDA Device recall Z-0968-2020
Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108 by Cook, citing the wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0968-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-04 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | US |
Product
Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
Reason
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Identifiers
| code_info | NS8070854 8078209 8116743 |
|---|
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-0968-2020%22
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