Recalls / —

—#197442

Product

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

FDA product code

NEY — System, Ablation, Microwave And Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

Affected lot / code info

UDI/DI (GTIN): 10884521825765, Lot Number: 520200

Why it was recalled

The product is labeled with the incorrect expiration date.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm

Covidien, LLC

Address

161 Cheshire Ln N, Ste 100, Minneapolis, Minnesota 55441-5433

Distribution

Distribution pattern

Foreign Distribution: Hong Kong

Timeline

Recall initiated

2022-11-23

Posted by FDA

2023-01-12

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.