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U.S. Department of Health and Human Services

Class 2 Device Recall Cytosponge Cell Collection Device

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  Class 2 Device Recall Cytosponge Cell Collection Device see related information
Date Initiated by Firm June 06, 2016
Create Date July 05, 2016
Recall Status1 Terminated 3 on October 18, 2017
Recall Number Z-2122-2016
Recall Event ID 74300
510(K)Number K152794  
Product Classification Esophagoscope (flexible or rigid) - Product Code EOX
Product Covidien Cytosponge Cell Collection Kit.
Contains Cytosponge Cell Collection Device, Specimen Jar with preservative.
Item code CYTO-KIT-R

Gastroenterology: Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. Currently the device is only available for clinical studies.
Code Information Item Code: CYTO-KIT-R; Lot numbers: 3441120915, 3441102015
Recalling Firm/
Manufacturer		 Covidien, LLC
540 Oakmead Pkwy
Sunnyvale CA 94085-4022
For Additional Information Contact David A. Cannistraci
763-398-7490
Manufacturer Reason
for Recall		 Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during withdrawal from the patient's esophagus.
FDA Determined
Cause 2		 Process control
Action The firm, Medtronic, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 6, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to quarantine and discontinue use; return affected product to Medtronic/Covidien, Quality Department, 540 Oakmead Parkway, Sunnyvale CA 94085; complete and return the RECALLED PRODUCT RETURN FORM by email to Customer Service feedback.customerservice@Covidien or fax to (800)-895-6140 if product purchased directly from Medtronic; or by email to Quality Compliance MITGFCA@Covidien.com or fax to (203) 492-7719 if Product purchased through distributor or you have "no inventory"; and to promptly alert any other person or facilities if they have further distributed the product. All affected lots must be returned. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in Commerce 620 total units (260 US; 360 OUS)
Distribution Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = EOX and Original Applicant = Covidien LLC
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