—#152289

Product

Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010

FDA product code: GBZ — Catheter, Cholangiography
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K831931
Affected lot / code info: All Lot Numbers With Expiration Date Prior To December 2019

Why it was recalled

Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)

Root cause (FDA determination)

Labeling design

Action the firm took

Marquet/Atrium notified consignees by letter dated 01/20/17 informing of the Labeling Icon Clarification. The thoracic catheter labeling is being updated for future production. Users should be made aware of this Field Notification and may continue to use the affected thoracic catheter products with the current labeling. Questions, please contact your local Maquet/Atrium thoracic catheter representative or Maquet Customer Service at 1-800-528-7486 or 603-880-1433, Monday through Friday between 8:00 am and 5:00 pm (EST).

Recalling firm

Firm: Atrium Medical Corporation
Address: 5 Wentworth Dr, Hudson, New Hampshire 03051-4929

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2017-01-20
Terminated: 2020-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.