COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

FDA device recall Z-0955-2023 · posted 2023-01-12 · Open, Classified

Recall details

Recalling firm

Covidien, LLC

Reason for recall

The product is labeled with the incorrect expiration date.

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.

Root cause

Process control

Status

Open, Classified

Product code

NEY

Quantity affected

21 units

Distribution

Foreign Distribution: Hong Kong

Date initiated

2022-11-23

Date posted

2023-01-12

Location

Minneapolis, MN