Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-US
Summary
The FDA issued a Class II for Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytospon by Covidien, LLC. 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 lea.
Details
Source
Device Recall
External ID
Z-2282-2023
Action Date
2023-08-09
Status
Ongoing
Category
device
Product Description
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Lot/Code Info: REF/UDI-DI/Lot: CYTO-201/20884521767789/22E1619JZX, 22F0680JZX, 22F0950JZX, 22G0007JZX, 22G0008JZX, 22G0723JZX, 22G0724JZX, 22H0017JZX, 22H0018JZX, 22H0019JZX, 22H0820JZX, 22H0821JZX, 22H1158JZX, 22H1159JZX, 22H1161JZX, 22J0162JZX, 22J0163JZX, 22J0164JZX, 22J1030JZX, 22K0966JZX, 22K0967JZX, 23B0301JZX, 23B0303JZX; CYTO-KIT-USM/10884521546257/22G0635JZX, 22E1624JZX, 22E1625JZX.
Quantity Affected: 6902
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.
Distribution
Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-02
Company
Santa Clara, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LLC has 61 FDA actions in our database, including 41 recalls and 20 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Covidien, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LLC have FDA actions?
Covidien, LLC has 61 FDA actions in our database, including 41 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2282-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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