FDA Device recall Z-0448-2020
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter…
- FDA Device
- Class II
- terminated
- Published 2019-11-27
On 2019-11-27 the FDA classified a Class II recall of Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arter… by Cook, citing the potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0448-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-21 |
| Published | 2019-11-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | US |
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
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
Identifiers
| code_info | REF (RPN): HNB5.0-38-100-P-10S-0 REF (GPN): G07268 Lot Numbers: 9693491, 9696896, 9700377, 9700378, 9700379, 9710398,…REF (RPN): HNB5.0-38-100-P-10S-0 REF (GPN): G07268 Lot Numbers: 9693491, 9696896, 9700377, 9700378, 9700379, 9710398, 9716496, NS9712994 UDIs: (01)00827002072688(17)220508(10)9693491, (01)00827002072688(17)220508(10)9696896, (01)00827002072688(17)220508(10)9700377, (01)00827002072688(17)220509(10)9700378, (01)00827002072688(17)220510(10)9700379, (01)00827002072688(17)220515(10)9710398, (01)00827002072688(17)220517(10)9716496, (01)00827002072688(17)220516(10)NS9712994 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0448-2020%22
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