Recall Z-0432-2020— Cook Inc.
Class II · Terminated
Class II FDA medical device recall by Cook Inc., initiated 2019-10-21, terminated 2020-06-30. It names one FDA 510(k) clearance: K133130. 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..
- Recalling firm
- Cook Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-21
- Terminated
- 2020-06-30
- Firm location
- Bloomington, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.