FDA Device recall Z-0949-2018
Amplatz Stiff Wire Guide
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Amplatz Stiff Wire Guide by Cook, citing label does not state that the product is heparin-coated.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0949-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-13 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cook |
| Distribution | n/a |
Product
Amplatz Stiff Wire Guide
Reason
Label does not state that the product is heparin-coated.
Identifiers
| code_info | Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 |
|---|
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-0949-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.