TFE Coated Curved Newton LLT — Class II medical device recall Z-0963-2018
Terminated recall by Cook Inc., reported 2018-03-21. Label does not state that the product is heparin-coated.
| Recall number | Z-0963-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2017-10-13 |
| Classified | 2018-03-09 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-10-23 |
| Quantity | 3,364 |
| Reason classes | labeling |
| Model numbers | TSCFNB-35-180-SPENCERMOD |
Product
TFE Coated Curved Newton LLT
Reason for recall
Label does not state that the product is heparin-coated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0963-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.