Torcon NB Advantage Catheters — Class II medical device recall Z-0466-2020
Terminated recall by Cook Inc., reported 2019-11-27, distributed nationwide. The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of
| Recall number | Z-0466-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2019-10-21 |
| Classified | 2019-11-18 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2020-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 25 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00827002107274 |
| Lot numbers | 9718544 |
| Model numbers | 9718544, G10727, HNB5.0-38-100-P-NS-JR5 |
Product
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
Reason for recall
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
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-0466-2020. 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.