Recall Z-2282-2023— Covidien, LLC
Class II · Ongoing
Class II FDA medical device recall by Covidien, LLC, initiated 2023-06-02. It names one FDA 510(k) clearance: K181020. Product: Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM. Reason: Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration..
- Recalling firm
- Covidien, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-02
- Firm location
- Santa Clara, CA, 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
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Reason for recall
Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.