Recall Z-2122-2016
Covidien, LLC · initiated June 6, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Item Code: CYTO-KIT-R; Lot numbers: 3441120915, 3441102015
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: Process control
Action taken
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.
Details
- Recall number
- Z-2122-2016
- Initiated
- June 6, 2016
- Terminated
- October 18, 2017
- Product code
- EOX – Esophagoscope (Flexible Or Rigid)
- Quantity
- 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.
- Recalling firm
- Covidien, LLC, Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2123-2016 Class II | Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastroenterology:…Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the… | 06/06/2016Terminated |