—#147105

Product

Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology: -.Cytosponge Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus. This device is currently only being used in clinical studies.

FDA product code: EOX — Esophagoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K152794
Affected lot / code info: Item Code: CYTO-101-01. Lot numbers: F2500566X, F2500628X, F2500202X, F2500351X.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Covidien, LLC
Address: 540 Oakmead Pkwy, Sunnyvale, California 94085-4022

Distribution

Distribution pattern: Worldwide Distribution-US Distribution to TN, NC, IL, CA, MN, OR and NY; and countries of: United Kingdom and Iran.

Timeline

Recall initiated: 2016-06-06
Terminated: 2017-10-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147105. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.