Recall Z-0955-2023
Covidien, LLC · initiated November 23, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Codes / lots: UDI/DI (GTIN): 10884521825765, Lot Number: 520200
Reason for recall
The product is labeled with the incorrect expiration date.
FDA-determined cause: Process control
Action taken
On about 11/23/2022, the single customer was notified with an "URGENT: MEDICAL DEVICE RECALL" letter via visit. The letter instructed the consignee to immediately identify, segregate, and quarantine affected products within your inventory, pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred, and to contact Medtronic to return affected product. Additionally. the consignee was instructed to complete and return the customer confirmation form even if you do not have any affected units. Return the form via email to RS.GMBFCAMITG@medtronic.com within 30 days of receipt. Contact us at 1-800-255-6774 to receive a return material authorization (RMA) and coordinate inventory replacement/credit. Return unopened affected units to: Medtronic Attention: [Insert RGA #], 4340 Swinnea Rd, Bldg A Memphis, TN 38118. If you have any questions regarding this communication, please contact your Medtronic Representative or Medtronic Customer Service at 800-962-9888.
Details
- Recall number
- Z-0955-2023
- Initiated
- November 23, 2022
- Posted by FDA
- January 12, 2023
- Product code
- NEY – System, Ablation, Microwave And Accessories
- Quantity
- 21 units
- Distribution
- Foreign Distribution: Hong Kong
- Recalling firm
- Covidien, LLC, Minneapolis, MN