FDA Device recall Z-0960-2018
Newton Wire Guide
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Newton 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-0960-2018 |
| 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
Newton Wire Guide
Reason
Label does not state that the product is heparin-coated.
Identifiers
| code_info | Catalog #THSCFNB-/-BH TSCFNA-BH TSCFNB-/-BH TSFNA-/-BH TSFNB-/-BH Affected lots range from: 3733537 - 5803299 F…Catalog #THSCFNB-/-BH TSCFNA-BH TSCFNB-/-BH TSFNA-/-BH TSFNB-/-BH Affected lots range from: 3733537 - 5803299 F3762971 - F4692445 NS5043714 - NS5900771 3766161 - 5925080 F3753484 - F4887253 NS4938982 - NS5932560 F4556472 - F4718761 NS6024246 3741877 - 5929842 F3749985 - F4903656 NS4928037 - NS5963186 3744567 - 6253002 F3763300 - F4900931 NS4928039 - NS59824 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180 |
|---|
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-0960-2018%22
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