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U.S. Department of Health and Human Services

Class 2 Device Recall CytospongeTM Cell Collection Device CytospongeTM Cell Collection Kit

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  Class 2 Device Recall CytospongeTM Cell Collection Device CytospongeTM Cell Collection Kit see related information
Date Initiated by Firm June 02, 2023
Date Posted August 02, 2023
Recall Status1 Open3, Classified
Recall Number Z-2282-2023
Recall Event ID 92560
510(K)Number K181020  
Product Classification Esophagoscope (flexible or rigid) - Product Code EOX
Product Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Code Information 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.
Recalling Firm/
Manufacturer		 Covidien, LLC
3062 Bunker Hill Ln
Santa Clara CA 95054-1105
For Additional Information Contact Medtronic Customer Service
800-962-9888
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action On 6/2/23, Medtronic sent recall notices to customers who were informed of the following: 1) If product was purchased directly from Medtronic, return affected product to Medtronic. 2) If product was purchased from a distributor, return affected product to the distributor. 3) The recall notice should be passed on to all who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 4) Complete and return the Customer Confirmation Form to rs.gmbfcamitg@medtronic.com Adverse reactions or quality problems experienced with this product can be reported to Technical Support at dl.gi-usdl-ustecchsupport@medtronic.com or call 1-800-448-3644 option 3.
Quantity in Commerce 6902
Distribution Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EOX and Original Applicant = Covidien llc
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