FDA Device recall Z-0963-2018
TFE Coated Curved Newton LLT
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of TFE Coated Curved Newton LLT 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-0963-2018 |
| 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
TFE Coated Curved Newton LLT
Reason
Label does not state that the product is heparin-coated.
Identifiers
| code_info | Catalog # TSCFNB-35-180-SPENCERMOD- BH Affected lots to include: 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-0963-2018%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.